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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... 

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