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Analytical Methods for Determination of Salbutamol, Ambroxol and Fexofenadine

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Review Article | DOI: https://doi.org/10.31579/2766-2314/004

Analytical Methods for Determination of Salbutamol, Ambroxol and Fexofenadine

  • Yara Elkady 1
  • Sobhy M. El-Adl 1
  • Mohamed Baraka 1
  • Mahmoud M. Sebaiy 1*

Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.

*Corresponding Author: Mahmoud M. Sebaiy, Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.

Citation: Yara Elkady, Sobhy M. El-Adl, Mohamed Baraka and Mahmoud M. Sebaiy (2020) Analytical Methods for Determination of Salbutamol, Ambroxol and Fexofenadine J, Biotechnology and Bioprocessing 1(1); DOI: 10.31579/2766-2314/004

Copyright: © 2020, Mahmoud M. Sebaiy, This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 08 September 2020 | Accepted: 15 September 2020 | Published: 16 October 2020

Keywords: salbutamol; ambroxol; fexofenadine

Abstract

In this review article, we will introduce all reported methods that have been developed for determination of certain anti-tussive and anti-histaminic drugs such as salbutamol, ambroxol and fexofenadine in their pure form, combined form with other drugs, combined form with degradation products, and in biological samples. We also will shed the light on the most important combination of drugs that are used for treatment of asthma and related diseases.

Methods for analysis of Salbutamol

1.1. Chromatographic methods:

1.1.1. HPLC methods:

Table 1.

1.1.2. Thin Layer Chromatographic methods:

Table 2.

1.2. Spectrophotometric methods:

Table 3.

1.3. Spectrofluorimetric methods:

A basic, exact, reproducible and precise spectrofluorimetric strategy for estimation of Salbutamol sulfate (SAL) in mass medication and different measurements structures has been created. This technique depends on development of incorporation complex of SAL in β-cyclodextrin (BCD) which gives fluorescence at excitation frequency of 279.6 nm and emanation frequency of 609.8 nm in water. Arrangement of consideration complex of medication with BCD improves fluorescence power of medication prompts expanded affectability [35].

 A basic, quick and touchy spectrophotometric technique for the assurance of sulbutamol in unadulterated structure and in various pharmaceutical arrangements has been created. The charge move (CT) response between salbutamol as electron giver and 2,6-dichloroquinone chlorimide (DCQ) and 7,7,8,8-tetracyanoquinodimethane (TCNQ) as a π-electron acceptor have been spectrophotometrically contemplated. The ideal exploratory conditions for these CT responses have been concentrated cautiously. Brew's law is complied with over the focus scope of 1.0–30.0 μg ml−1 and 2.0–20.0 μg ml−1 for salbutamol utilizing DCQ and TCNQ, individually. For more exact outcomes, Ringbom ideal fixation extend is determined and seen as 10.0 to 30.0 and 8.0 to 20 μg ml−1 for salbutamol utilizing DCQ and TCNQ, individually. The Sandell affectability is seen as 0.011 and 0.010 g cm−2 for salbutamol utilizing DCQ and TCNQ, separately, which show the high affectability of the proposed strategies. Relative standard deviations (R.S.D.) of 0.27 to 0.68% and 0.20 to 1.40% (n=5) were acquired for five reproduces of salbutamol utilizing DCQ and TCNQ, individually. The outcomes got by the two reagents are practically identical with those gotten by British pharmacopeia examine for the assurance of salbutamol in crude materials and in pharmaceutical arrangements [36].

1.4. Capillary electrophoresis methods:

A strategy for the assurance of clenbuterol and salbutamol in takes care of by capillary electrophoresis was set up. The states of test pretreatment and electrophoretic investigation were enhanced. The recuperations of clenbuterol were between 83.2 % and 94.5% with a discovery breaking point of 0.02? μg/mL, while the recuperations of salbutamol were somewhere in the range of 82.5% and 93.7% with a recognition cutoff of 0.03? μg/mL [37].

Another technique for sorption and centralization of salbutamol in pee joined to fine electrophoresis with UV identification was performed. The strategy depends on the sorption of salbutamol on dissolvable impregnated pitches that is set up by an impregnation procedure utilizing Aliquat 336 as extractant and XAD-4 sap as the base polymer. Group contemplates indicated an effective sorption/desorption results when the salbutamol arrangement contains NaOH 0.05 mol L− 1 and the eluent is 0.5 mol L− 1 NaCl. Linearity was acquired in the scope of 1000–10,000 ng mL− 1 of salbutamol. The constraint of measurement was 999 ng mL− 1. The dissolvable impregnated gum was utilized for 10 cycles without a huge loss of the salbutamol measurement limit. The strategy was applied to examine salbutamol in pee tests at levels valuable for global wellbeing associations [38].

Metods for analysis of Ambroxol

2.1. Chromatographic methods:

2.1.1. HPLC methods:

Table 4.

2.1.2. Thin Layer Chromatographic methods:

Table 5.

2.2. Spectrophotometric methods:

Table 6.

2.3. Capillary electrophoresis methods:

A sensitive and rapid capillary electrophoretic method combined with laser-induced fluorescence detection has been created for the assurance of ambroxol. Tests were derivatized with 5·10−4 M fluorescein isothiocyanate. A straight connection among fixation and pinnacle region was gotten in the focus run 0.008–42 μg ml−1 with a relationship coefficient of 0.9999. The strategy is likewise valuable for the assurance of ambroxol in pharmaceutical arrangements. [59].

 Expectorant drugs ambroxol (AMB) and bromhexine (BX) were dictated by fine isotachophoresis (ITP) with conductimetric location. The main electrolyte (LE) was a cradle arrangement that contained 5 mM picolinic corrosive and 5 mM potassium picolinate (pH 5.2). The ending electrolyte (TE) was 10 mM formic corrosive. The driving current was 80 microA (for roughly 200 s) or 50 microA (for around 350 s) and the location current was 20 microA (a solitary investigation took around 8 min). The successful mobilities of AMB and BX (assessed with tetraethylammonium as the portability standard) were 18.8 x 10(- 9) m2 V(- 1) s(- 1) and 14.3 x 10(- 9) m2 V(- 1) s(- 1) separately. The alignment charts relating the ITP zone length to the grouping of the analytes were rectilinear (r = 0.9993-0.9999) in the range 10 mg L(- 1) (20 mg L(- 1) for BX) to 200 mg l(- 1) of the medication standard. The relative standard deviations (RSD) were 1.2 1.6% (n = 6) while deciding 100 mg l (- 1) of the analytes in unadulterated test arrangements. The strategy has been applied to the measure of AMB or BX in seven business mass-created pharmaceutical arrangements. As per the approval strategy dependent on the standard expansion procedure the recuperations were 97.5-102.7% of the medication and the RSD esteems were 0.11-2.20% (n = 6) [60].

Metods for analysis of Fexofenadine

3.1. Chromatographic methods:

3.1.1. HPLC methods:

Table 7.

3.1.2. Thin Layer Chromatographic methods:

Table 8.

3.2. Spectrophotometric methods:

Table 9.

3.3. Capillary electrophoresis methods:

A basic, precise, and viable capillary electrophoresis strategy with bright absorbance recognition was created and approved for the quantitation of the antihistamine fexofenadine in cases. The partition was performed with an uncoated melded silica fine (47 cm x 75 microm id) and was worked at 20 kV potential. Temperature was kept up at 25 degrees C. The run support was set up with 20mM Na2B4O7 x 10 H2O. Programming was utilized for framework control, information procurement, and examination. Technique approval was performed by assessment of the systematic boundaries linearity, exactness, precision, cutoff points of discovery and quantitation, and explicitness. The strategy was direct (r = 0.9999) at fixations running from 20 to 100 microg/mL, exact (relative standard deviation intra-measure = 1.2, 1.6, and 1.8% and interassay = 1.5%); precise (recuperation = 98.1%); and explicit. The constraints of discovery and quantitation were 0.69 and 2.09 microg/mL, individually. The strategy was contrasted with the fluid chromatography technique grew already by the writers for a similar medication, and no huge distinction was found between the 2 strategies in fexofenadine hydrochloride quantitation [86].

Capillary electrophoresis (CE) methods for the assurance of FEX in pharmaceuticals were done. It was exhibited that FEX could be viably broke down in free arrangement cationic CE at low pH. Another diagnostic methodology contemplated depended on cyclodextrin (CD) changed CE where profoundly charged CD subordinates filled in as analyte transporters. Along these lines, the partition go was spread to physiological pH area and a CE examination of FEX, present really in its zwitterionic structure, could be cultivated. A few boundaries influencing the partitions were examined, including the sort and grouping of transporter particle, counterion, analyte transporter, and pH of the cradle. The techniques dependent on the free arrangement CE and CD-adjusted CE were analyzed one another, approved, and applied for the assurance of FEX in tablets. [87].

3.4. Luminescence methods:

Technique for the assurance of Fexofenadine (FEX), in pharmaceutical details is accounted for. The strategy depends on the refinement of terbium (Tb3+) by complex development with FEX. The glow signal for Tb–FEX complex is enormously upgraded by the expansion of triethylamine (ET3N) and zinc nitrate in methanol arrangement. Observing of the sign is practiced when the instrument is in the glow mode with the excitation and emanation frequencies set at λex = 220 nm and λem = 550 nm separately. Ideal conditions for the arrangement of the complex in methanol were 2.25 × 10−6 M of Tb3+, 5.00 × 10−6 M of Et3N and Zn2+ which takes into consideration the assurance of 10–800 ppb of FEX in the clump mode with a recognition cutoff of 0.3 ppb. The proposed strategy was effectively applied for the assurance of FEX in pharmaceutical plans [88].

3.5. Graphite Electrode methods:

A new electrochemical approach for the attending assurance of fexofenadine hydrochloride and montelukast sodium by developing three new graphite cathodes covered with a polymeric film. The first cathode was built utilizing ammonium molybdate reagent as a particle pair with fexofenadine cation for the assurance of fexofenadine sedate, the subsequent anode was developed utilizing cobalt nitrate as a particle pair with montelukast anion for the assurance of montelukast medicate, the third terminal was set up by fusing the two beforehand notice particle sets in a similar graphite sensor, which cause this sensor touchy to each to fexofenadine and montelukast tranquilize. The covering material was a polymeric lm includes Poly Vinyl Chloride (PVC), Di-butyl phthalate as a plasticizer (DBP), particle sets of medications with recently referenced reagents. The terminals indicated a Nernstian reaction with a mean adjustment chart slants of [58.97, 28.43, (59.048, and 28,643)] mv.decade-1 for the three pencil anodes separately. The anodes work successfully over pH run (2-4.5) for fexofenadine hydrochloride and (5-9.5) for montelukast sodium. The effect of the proposed meddling species was negligible. The viability of the cathodes proceeded in a timeframe (45-69) days. The recommended sensors exhibited valuable expository highlights for the assurance of the two medications in mass powder, in lab arranged blends and their consolidated dose structure [89]. 

Conclusion

This literature review represents an up to date survey about all reported methods that have been developed for determination of salbutamol, ambroxol and fexofenadine in their pure form, combined form with other drugs, combined form with degradation products, and in biological samples such as liquid chromatography, spectrophotometry, spectroflourimetry, etc... 

References

  1. Tsai CE1, Kondo F. (1994). Liquid chromatographic determination of salbutamol and clenbuterol residues in swine serum and muscle, 80(325):251-8.
    View at Publisher | View at Google Scholar
  2. J Chromatogr A. , Li C1, Wu YL, Yang T, Zhang Y, Huang-Fu WG. (2010). Simultaneous determination of clenbuterol, salbutamol and ractopamine in milk by reversed-phase liquid chromatography tandem mass spectrometry with isotope dilution. 1217(50):7873-7.
    View at Publisher | View at Google Scholar
  3. Mi J1, Li S, Xu H, Liang W, Sun T.(2014). Rapid analysis of three β-agonist residues in food of animal origin by automated on-line solid-phase extraction coupled to liquid chromatography and tandem mass spectrometry. 37(17):2431-8.
    View at Publisher | View at Google Scholar
  4. lvis Martis,Deepali Gangrade (2010) reverse phase isocratic hplc method for simultaneous estimation of salbutamol sulphate and beclomethasone dipropionate in rotacaps formulation dosage forms elvis a martis,3(1) 64-67.
    View at Publisher | View at Google Scholar
  5. Dubey, N., Sahu, S. and Singh, G.N. (2012). Development of HPLC method for       simultaneous estimation of ambroxol, guaifenesin and salbutamol in single dose form. Indian Journal of Chemistry - Section B Organic and Medicinal Chemistry. 51. 1633-1636.
    View at Publisher | View at Google Scholar
  6. HassanY.Aboul-Enein & SuhairAbu-Zaid, (2001) two-dimensional TLC method for identification and quantitative analysis of salbutamol and related impurities in pharmaceutical tablet formulation. 34(12) p.2099-2110
    View at Publisher | View at Google Scholar
  7. A.shalaby, (2006).Simple HPLC Method for the Analysis of Some Pharmaceuticals. 21(20) p.3161-3171.
    View at Publisher | View at Google Scholar
  8. Kamatham, S.S., Kolli, S., Joga, D.D. and Yanamadala, B.D. (2013). Simultaneous estimation of salbutamol, ambroxol and guaifenesin in tablet dosage forms by using RP-HPLC.
    View at Publisher | View at Google Scholar
  9. Sohan S. Chitlange, Kaushalendra K. Chaturvedi and Sagar B. Wankhede, (2011). Development and Validation of Spectrophotometric and HPLC Method for the Simultaneous Estimation of Salbutamol Sulphate and Prednisolone in Tablet Dosage Form.
    View at Publisher | View at Google Scholar
  10. Kalyani, L., Chava, V. and Rao, N. (2017). Development and validation of stability-indicating RPHPLC method for the simultaneous analysis of Salbutamol, Theophylline and Ambroxol. Saudi J. Med. and Pharm. Sci, 2413-4929.‏
    View at Publisher | View at Google Scholar
  11. Njaria, P., Abuga, K., Kamau, F. and Chepkwony, H. (2016). A Versatile HPLC Method for the Simultaneous Determination of Bromhexine, Guaifenesin, Ambroxol, Salbutamol/Terbutaline, Pseudoephedrine, Triprolidine, and Chlorpheniramine Maleate in Cough–Cold Syrups. Chromatographia. 79.
    View at Publisher | View at Google Scholar
  12. Maha M. Abdelrahman, (2018) Solid-Phase Extraction and HPLC-DAD for Determination of Salbutamol in Urine Samples. P.35-45.
    View at Publisher | View at Google Scholar
  13. Papiya Bigoniya and Smita Mishra Radharaman, (2016) simultaneous hplc method development and validation for estimation of salbutamol in combination with vasicine.
    View at Publisher | View at Google Scholar
  14. Ghulam Murtaza,Mahmood Ahmad,Muhammad Asadullah Madni,Muhammad Waheed Asgha,(2009). A new reverse phase hplc method with fluorescent detection for the determination of salbutamol sulfate in human plasma. 23(1), 1-8.
    View at Publisher | View at Google Scholar
  15. Sawant Ramesh L., Bharat Anjali V, Tanpure Kallyani D., Jadhav Kallyani A. Pad. Dr. Vitthalrao Vikhe Patil. (2015) A new rp-hplc method development for simultaneous estimation of salbutamol sulphate, theophylline and furosemide.
    View at Publisher | View at Google Scholar
  16. Rao, N., and K. D. Gawde. (2018), “Method development and force degradation studies for simultaneous and bromhexine hydrochloride in pharmaceutical dosage form using reversed-phase high-performance liquid chromatography method”. Asian Journal of Pharmaceutical and Clinical Research, 11(8), pp. 378-82
    View at Publisher | View at Google Scholar
  17. Pai, P. N., Rao, G. K., Murthy, M. S., Agarwal, A. and Puranik, S. (2009). Simultaneous determination of salbutamol sulphate and bromhexine hydrochloride in tablets by reverse phase liquid chromatography. Indian journal of pharmaceutical sciences, 71(1), 53–55.
    View at Publisher | View at Google Scholar
  18. Patel, N. and Parmar, V.K. (2018). A Sensitive High-Performance Thin Layer Chromatography Method for Simultaneous Determination of Salbutamol Sulphate and Beclomethasone Dipropionate from Inhalation Product. Pharm Sci; 24(2): 131-140.
    View at Publisher | View at Google Scholar
  19. Naguib IA, Abdelaleem EA, Farag SA, Zaazaa HE (2017) Simultaneous determination of guaifenesin, salbutamol sulfate or dextromethorphan HBr and guaifenesin impurity (Guaiacol) by HPTLC. Method Anal Chem Lett 7:142–152.
    View at Publisher | View at Google Scholar
  20. Tyagi, A., Sharma, A., Mittal, K., Mashru, R., e al., (2015). HPTLC-Densitometric and RP-HPLC Method Development and Validation for Determination of Salbutamol Sulphate, Bromhexine Hydrochloride and Etofylline in Tablet Dosage Forms. Pharmaceutica Analytica Acta. 06.
    View at Publisher | View at Google Scholar
  21. Dave, H., Mashru, R., and Patel, A.K., (2010). Thin Layer Chromatodraphy Method for the Determination of Ternary Mixture Containing Salbutamol Sulphate, Bromhexine Hydrochloride and Etofylline. Journal of Pharmaceutical Sciences and Research. 2. 143-148.
    View at Publisher | View at Google Scholar
  22. Samir, A., Lotfy, H.M., Salem, H., and Abdelkawy, M. (2014). Development and validation of simultaneous spectrophotometric and TLC-spectrodensitometric methods for determination of beclomethasone dipropionate and salbutamol in combined dosage form. Biomolecular Spectroscopy. 128, 127-136.
    View at Publisher | View at Google Scholar
  23. Aboul-Enein, H.., and Abu-Zaid, S. (2001). Two-dimensional TLC method for identification and quantitative analysis of salbutamol and related impurities in pharmaceutical tablet formulation, analytical letters, 34:12, 2099-2110.
    View at Publisher | View at Google Scholar
  24. Chaturvedi, K. and Chitlange, S. (2011). UV Spectroscopic and Stability-Indicating TLC-Densitometric Method for Simultaneous Estimation of Salbutamol sulphate and Prednisolone in Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry. 4. 786-790.
    View at Publisher | View at Google Scholar
  25. Kalyani L. and Rao C.V.N. (2018). Simultaneous spectrophotometric estimation of Salbutamol, Theophylline and Ambroxol three component tablet formulation using simultaneous equation methods.  Karbala International Journal of Modern Science, 4 (1), pp. 171-179.
    View at Publisher | View at Google Scholar
  26. Al-Hammoodi, I. A. and Al-Sabha, T. (2020). Application of Cloud Point Method for Spectrophotometric Determination of Salbutamol Sulphate and Methyldopa. Pak. J. Anal. Environ. Chem. 21, No. 1.
    View at Publisher | View at Google Scholar
  27. Abdel, K., Attia, S. M., Nassar, M. W. and Osman, A. (2016). Different spectrophotometric methods manipulating ratio spectra for simultaneous determination of salbutamol and bromhexine in binary mixture.‏ ACAIJ, 16(11) 2016.
    View at Publisher | View at Google Scholar
  28. Hadi, H. and Salim, G. (2017). Simultaneous Spectrophotometric Determination of Salbutamol by Coupling with Diazotized 4-Aminobenzoic acid. International Journal of Pharmaceutical Quality Assurance. 8.
    View at Publisher | View at Google Scholar
  29. Al-Da'amy, M. and Hassan, M. (2019). Spectrophotometric Determination Methyldopa and Salbutamol by Oxidative Coupling, Cloud Point and Flow Injection in Pharmaceutical Formulations. International Journal of Drug Delivery. 9(2). 182-192.
    View at Publisher | View at Google Scholar
  30. Abirami, G. and Vetrichelvan, T. (2017). Novel simultaneous and second order derivatve method development of doxofylline and salbutamol sulphate in pure and fixed dose combination by uv–spectrophotometry.‏ World Journal of Pharmaceutical Research.   Vol 6, Issue 8, 2017
    View at Publisher | View at Google Scholar
  31. Suryana, S., Nurjanah, N.S., Permana, B., Prasetiawati, R.  and Lubis, N. (2019). Derivative Uv-Spectroscopic determination of theophylline, salbutamol sulfate and glycerylguaicolate in syrup mixture. Journal of Physics: Conference Series, 1402, 5.
    View at Publisher | View at Google Scholar
  32. Mughni, N. T. F. (2019). Development of methods for determining theophylline, salbutamol sulfate and glycerylguaiacolate in a simultanneous multicomponent syrup preparation using ultraviolet spectrophotometry derivative.
    View at Publisher | View at Google Scholar
  33. Pandya, H. N., Berawala, H. H., Khatri, D. M. and Mehta, P. J. (2010). Spectrofluorimetric estimation of salbutamol sulphate in different dosage forms by formation of inclusion complex with β-cyclodextrin. Pharmaceutical methods, 1(1), 49–53.
    View at Publisher | View at Google Scholar
  34. Mohamed, G., Khalil, S., Zayed, M. and El-Shall, M. (2002). 2, 6-Dichloroquinone chlorimide and 7, 7, 8, 8-tetracyanoquinodimethane reagents for the spectrophotometric determination of salbutamol in pure and dosage forms. Journal of pharmaceutical and biomedical analysis. 28. 1127-33.
    View at Publisher | View at Google Scholar
  35. Chu, Q-C., Geng, C-H., Zhou, H. and Ye, J-N. (2007). Fast Determination of Clenbuterol and Salbutamol in Feed and Meat Products Based on Miniaturized Capillary Electrophoresis with Amperometric Detection. Chinese Journal of Chemistry - CHINESE J CHEM. 25. 1832-1835.
    View at Publisher | View at Google Scholar
  36. Pérez-Silva, I., Ramírez-Silva, M., Galán-Vidal, C., Álvarez Romero, G., Rodriguez, J. and Páez, E. (2016). Evaluation of the use of solvent impregnated resins in the analysis of salbutamol in human urine followed by capillary electrophoresis. Reactive and Functional Polymers. 105. 10.1016/j.reactfunctpolym.
    View at Publisher | View at Google Scholar
  37. Mao, Z., Wang, X., Di, X., Liu, Y., Zang, Y., Ma, D. and Liu, Y. (2017). Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study. Analytical Sciences. 33. 1099-1103.
    View at Publisher | View at Google Scholar
  38. Palur, K., Koganti, B. and Archakam, S. C. (2019). Chemometric-assisted RP-HPLC method for the simultaneous determination of ambroxol hydrochloride, terbutaline sulfate, and guaiphenesin in combined dosage form. Journal of Applied Pharmaceutical Science, 9(09), 092-097.‏
    View at Publisher | View at Google Scholar
  39. El-Sayed, H.M. and Hashem, H. (2020). Quality by Design Strategy for Simultaneous HPLC Determination of Bromhexine HCl and Its Metabolite Ambroxol HCl in Dosage Forms and Plasma. Chromatographia.
    View at Publisher | View at Google Scholar
  40. Maithani, M., Sahu, S., Chaudhary, A. and Singh, R. (2012). Development and validation of a novel RP-HPLC method for simultaneous determination of salbutamol sulfate, guaifenesin, and ambroxol hydrochloride in tablet formulation. Journal of Liquid Chromatography & Related Technologies. 35. 1156-1170.
    View at Publisher | View at Google Scholar
  41. Sharma, K., Bhatia, R., Anghore, D., Singh, V., Khare, R. and Rawal, R. (2018). Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for Simultaneous Estimation of Fexofenadine Hydrochloride, Montelukast Sodium and Ambroxol Hydrochloride in Tablet Dosage Form. Analytical Chemistry Letters. 8. 829-843.
    View at Publisher | View at Google Scholar
  42. Zahoor, A., Munir, H., Sheikh, Z. A. and Usmanghani, K. (2016). A Rapid and Simultaneous Determination of Ambroxol Hydrochloride, Methyl Parabene and Propyl Paraben in Mucol Ambroxol Syrup Dosage Form. RADS Journal of Pharmacy and Pharmaceutical Sciences, 4(1), 84-88
    View at Publisher | View at Google Scholar
  43. Itagimatha, N. and Manjunatha, D. H. (2019). RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. In Annales Pharmaceutiques Françaises (Vol. 77, No. 4, pp. 295-301). Elsevier Masson.
    View at Publisher | View at Google Scholar
  44. Komarov, T.N., Bogdanova, D.S., Miskiv, O.A., Aleshina, A.V., Shohin, I.E., Medvedev, Y.V., Bagaeva, N.S. and Korenskaya, I.M. (2019). Development and Validation of Salbutamol, Bromhexine, Ambroxol and Guauaifenesin Determination in Human Plasma by HPLC-MS/MS Method. Drug development & registration. 8(4):61-74. (In Russ.)‏
    View at Publisher | View at Google Scholar
  45. Patel, K. G., Shah, P. S. and Gandhi, T. R. (2016). Stability-indicating high-performance thin-layer chromatographic method for the estimation of ambroxol hydrochloride and doxofylline in a pharmaceutical formulation using experimental design in robustness study. JPC-Journal of Planar Chromatography-Modern TLC, 29(2), 132-139.‏
    View at Publisher | View at Google Scholar
  46. Jain P.S. (2010). Stability-indicating HPTLC determination of ambroxol hydrochloride in bulk drug and pharmaceutical dosage form. J Chromatogr Sci; 48(1):45-48.
    View at Publisher | View at Google Scholar
  47. Sakhare, R. S., Pekamwar, S. S. and Gitte, T. V. (2018). Article Details Stability indicating high performance thin-layer chromatography method for simultaneous estimation of ambroxol hydrochloride and loratadine in pharmaceutical dosage form.‏ Indian Drugs. 55 (8): 44-51.
    View at Publisher | View at Google Scholar
  48. Abdelkawy, M., Metwaly, F., El Raghy, N., Hegazy, M. and Fayek, N. (2011). Simultaneous determination of Ambroxol Hydrochloride and Guaifenesin by HPLC, TLC-Spectrodensitometric and multivariate calibration methods in pure form and in Cough Cold Formulations. J Chromatograph Separat Techniq, 2(03).‏
    View at Publisher | View at Google Scholar
  49. Agrawal, O.D., Shirkhedkar, A.A. and Surana, S.J. (2010). Simultaneous determination of levofloxacin hemihydrate and ambroxol hydrochloride in tablets by thin-layer chromatography combined with densitometry. J Anal Chem 65, 418–422 (2010).
    View at Publisher | View at Google Scholar
  50. Dhaneshwar, S. R., Dhoka, M. V., Chopade, S. S. and Bhusari, V. K. (2011). Validated HPTLC Method for Simultaneous Estimation of Amoxycillin trihydrate and Ambroxol hydrochloride in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical & Biological Research (AJPBR), 1(2).‏
    View at Publisher | View at Google Scholar
  51. Sagathiya, K. R. U. N. A. L. and Bagada, H. I. N. A. (2014). Development and validation of RP-HPLC and HPTLC method of analysis for simultaneous estimation of ambroxol HCL, dextromethorphan HBR and statistical comparison of developed methods. Int J Pharm Pharm Sci, 6(2), 312-6.‏
    View at Publisher | View at Google Scholar
  52. Ali, O. I., Ismail, N. S. and Elgohary, R. M. (2016). Validated derivative and ratio derivative spectrophotometric methods for the simultaneous determination of levocetirizine dihydrochloride and ambroxol hydrochloride in pharmaceutical dosage form. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 153, 605-611.‏
    View at Publisher | View at Google Scholar
  53. Luo, T., Zhang, H. and Chen, J. (2018). Dissolution Determination of Ambroxol Hydrochloride Orally Disinegreting Tablets. Herald of Medicine, 37(11), 1401-1403.‏
    View at Publisher | View at Google Scholar
  54. Hegazy, M. A., Boltia, S. A., Fayed, A. S. and Musaed, A. (2018). Advanced chemometrics manipulation of UV-spectroscopic data for determination of three co-formulated drugs along with their impurities in different formulations using variable selection and regression model updating. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 202, 359-367.‏
    View at Publisher | View at Google Scholar
  55. Sumithra, M., Yuvanesh, P. and Mistry, A. (2016). Analytical method development and validation of ambroxol hydrochloride by UV spectroscopy and forced degradation study and detection of stability. Research Journal of Pharmacy and Technology, 9(7), 794-800
    View at Publisher | View at Google Scholar
  56. Gaur, A. and Rathore, P. (2016). Simultaneous Estimation of Ambroxol Hydrochloride and Olopatadine in Formulated Tablet Dosage Form by UV Spectroscopic Method. International Journal of Pharmaceutical Quality Assurance, 7(04), 62-65.‏
    View at Publisher | View at Google Scholar
  57. Perez-Ruiz, T., Martı́nez-Lozano, C., Sanz, A. and Bravo, E. (2000). Sensitive method for the determination of ambroxol in body fluids by capillary electrophoresis and fluorescence detection. Journal of Chromatography B: Biomedical Sciences and Applications, 742(1), 205-210.‏
    View at Publisher | View at Google Scholar
  58. Pospísilová, M., Polásek, M. and Jokl, V. (2001). Determination of ambroxol of bromhexine in pharmaceuticals by capillary isotachophoresis. Journal of pharmaceutical and biomedical analysis. 24. 421-8.
    View at Publisher | View at Google Scholar
  59. Helmy, S. A. and El Bedaiwy, H. M. (2015). HPLC determination of fexofenadine in human plasma for therapeutic drug monitoring and pharmacokinetic studies. Biomedical Chromatography, 30(7), 1059-1064.‏
    View at Publisher | View at Google Scholar
  60. Boloori, V., Qomi, M., Piroozi, F. and Raofie, F. (2016). Development of a simple and efficient method for preconcentration and determination of trace levels of fexofenadine in plasma and urine samples. Journal of Applied Chemical Research, 10(3), 7-14.‏
    View at Publisher | View at Google Scholar
  61. Malothu, N., Paladugu, T. and Katamaneni, P. (2018). Development and Validation of RP-HPLC Method for Determination of Fexofenadine in Pharmaceutical Dosage Form by Using Levocetirizine as an Internal Standard. Int. J. Pharm. Biol. Sci, 8, 619-625.
    View at Publisher | View at Google Scholar
  62. Sanam, S., Nahar, S., Saqueeb, N. and Rahman, S. A. (2018). A Validated RP-HPLC Method and Force Degradation Studies of Fexofenadine Hydrochloride in Pharmaceutical Dosage Form. Dhaka University Journal of Pharmaceutical Sciences, 17(1), 43-50.‏
    View at Publisher | View at Google Scholar
  63. Kayesh, R., Sarker, A. S. M., Sultan, M. and Jahan, M. (2017). A simple and improved HPLC-PDA method for simultaneous estimation of fexofenadine and pseudoephedrine in extended release tablets by response surface methodology. Journal of Chemistry, 2017.‏
    View at Publisher | View at Google Scholar
  64. Ukundamma, V., Vageesh, N. and Kistayya, C. (2018). Simultaneous estimation of montelukast and fexofenadine in pure and pharmaceutical dosage form by using RP-HPLC method. Innovat International Journal of Medical & Pharmaceutical Sciences, 3(1).‏
    View at Publisher | View at Google Scholar
  65. Gulhane, C. A., Khadabadi, S. S. and Atram, S. C. (2019). Analytical Method Development and Validation for Simultaneous Estimation of some drugs in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis, 9(3), 107-112.
    View at Publisher | View at Google Scholar
  66. Mirza, A. Z., Arayne, M. S. and Sultana, N. (2017). HPLC method development, validation and its application to investigate in vitro effect of pioglitazone on the availability of H1 receptor antagonists. Journal of the Association of Arab Universities for Basic and Applied Sciences, 22, 70-75.
    View at Publisher | View at Google Scholar
  67. Rele, R. V. (2016). Determination of fexofenadine hydrochloride in pharmaceutical dosage form by reverse phase high performance liquid chromatography method. Der Pharmacia Lettre, 8(6), 224-228.‏
    View at Publisher | View at Google Scholar
  68. Maher, H.M., Sultan, M.A. and Olah, I.V. (2011). Development of Validated Stability-Indicating Chromatographic Method for the Determination of Fexofenadine Hydrochloride and Its Related Impurities in Pharmaceutical Tablets. Chem. Central J. 5, 10.
    View at Publisher | View at Google Scholar
  69. Nimje, H. M., Shital Nimje, T., Oswal, R. J. and Bhamre, S. T. (2012). Stability Indicating RP-HPLC Method for Estimation of Fexofenadine Hydrochloride in Pharmaceutical Formulation. E- J. Chem, 9, 1257–1265.
    View at Publisher | View at Google Scholar
  70. Patnaik, A., Panda, S. S., Sahoo, S. and Patro, V. J. (2012). RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and Its Pharmaceutical Formulations. E- J. Chem. 9, 35 –42.
    View at Publisher | View at Google Scholar
  71. Kumar, G. V., Rajesh, T. and Chandra, J. (2018). A Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Bulk and Pharmaceutical Dosage Form. Indo Am. J. P. Sci. 5, 16756–16765.
    View at Publisher | View at Google Scholar
  72. Rajeev Kumar, P. and Kumar, R. R. (2017). Validated Stability-Indicating Isocratic RP-HPLC Method of Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Bulk and in Solid Dosage by Vierodt’s Method. J. Chem. Pharm. Res. 9, 297–243.
    View at Publisher | View at Google Scholar
  73. Sutar, P. M., Bansode, D. A. and Dhaneshwar, S. S. (2015). Stability Indicating Thin-Layer Chromatographic Determination of Fexofenadine Hydrochloride as Bulk Drug: Application to Forced Degradation Study. Der Pharma. Sin.  6, 3039.
    View at Publisher | View at Google Scholar
  74. Vekaria, H., Muralikrishna, K. S. and Mandip, S. (2012). Development and Validation of HPTLC Method for Simultaneous Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Combined Dosage Form. Der Pharmacia Lettre. 2011, 4, 755–762.
    View at Publisher | View at Google Scholar
  75. Tamilselvi, N., Sruthi, K., Arivukkarasu, R., Vanathi, P. and Visakh, D. (2016). Development of validated HPTLC method for simultaneous estimation of fexofenadine hydrochloride and montelukast sodium in tablet dosage form. Research Journal of Pharmacy and Technology, 9(4), 469-473.‏
    View at Publisher | View at Google Scholar
  76. Mahmood, S., Ahmad, Z. and Arshad, M. (2018). Estimation of fexofenadine hcl and pseudoephedrine hcl by spectrophotometer and TLC in combined tablet dosage form. Open J. Chem., 1 (1), pp. 01-11.
    View at Publisher | View at Google Scholar
  77. Sowjanya, G. and Sastri, K. T. (2017). UV spectrophotometric method development and validation for simultaneous determination of fexofenadine hydrochloride and montelukast sodium in tablets. World J. Pharm. Pharm. Sci, 6, 780-789.‏
    View at Publisher | View at Google Scholar
  78. Raghu, M. S., Shantharam, C. S. and Yogesh Kumar, K. (2018). Application of Bromate-Bromide Mixture as a Green Brominating Agent for the Determination of Fexofenadine Hydrochloride Pharmaceutical Dosage Form. J. Anal. Pharm. Res, 7, 13-21.‏
    View at Publisher | View at Google Scholar
  79. El-Didamony, A. M. and Ramadan, G. M. (2020). Charge-transfer interaction between antihistamine antiallergic drugs, diphenhydramine, fexofenadine, cetirizine and two π-acceptors in pharmaceutical forms. SN Applied Sciences, 2(4), 1-14.‏
    View at Publisher | View at Google Scholar
  80. Narayana, B. and Veena, K. A. (2010). New Method for the Spectrophotometric Determination of Fexofenadine Hydrochloride. Indian J. Chem. Technol. 17, 386–390.
    View at Publisher | View at Google Scholar
  81. Breier, A., Garcia, S., Jablonski, A., Steppe, M. and Schapoval, E. (2005). Capillary Electrophoresis Method for Fexofenadine Hydrochloride in Capsules. Journal of AOAC International. 88. 1059-63.
    View at Publisher | View at Google Scholar
  82. Mikuš, P., Valásková, I. and Havránek, E. (2005). Determination of Fexofenadine in Tablets by Capillary Electrophoresis in Free Solution and in Solution with Cyclodextrins as Analyte Carriers. Drug development and industrial pharmacy. 31. 795-801.
    View at Publisher | View at Google Scholar
  83. Al-Kindy, S. M., Al-Shamalani, K., Suliman, F. O. and Al-Lawati, H. A. (2019). Terbium sensitized luminescence for the determination of fexofenadine in pharmaceutical formulations. Arabian Journal of Chemistry, 12(8), 2457-2463.‏
    View at Publisher | View at Google Scholar
  84. Nashed, D., Noureldin, I. and Sakur, A. A. (2020). Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium Using New Pencil Graphite Electrode in Their Pure, Synthetic Mixtures, and Combined Dosage Form.
    View at Publisher | View at Google Scholar
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