Simultaneous determination of Ambroxol Hydrochloride and Guaifenesin by HPLC, TLC-Spectrodensitometric and multivariate calibration methods in pure form and in Cough Cold Formulations

Abdelkawy, Mohamed; Metwaly, Fadia H.; Raghy, N. El

doi:10.4172/2157-7064.1000112

Cited by 16 publications

(9 citation statements)

References 25 publications

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“…Pure samples of GUA racemate and AMB were obtained from Tenth of Ramadan for Pharmaceutical Industries and Diagnostic Reagents (Rameda), sixth of October, Egypt. According to a reported HPLC method, purity of GUA and AMB were 99.23% and 99.28%, respectively. The racemic nature of GUA pure form was confirmed by measuring its optical rotation in 95% ethanol (sodium D line, 2‐dm cells) and found to be optically inactive.…”

Section: Methodsmentioning

confidence: 96%

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Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50‐mm chiral column for a negligible environmental impact

2019

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Chiral stationary phases are conveniently used for enantiomeric separation of drugs by liquid chromatography. Consumption of large volumes of hazardous solvents is considered as a common challenge for the sustainability of this technique. To this end, a columnar chromatography has been adopted using 50mm-length stationary phases. The study comprised five Phenomenex Lux cellulose-and amylose-based columns for the separation of guaifenesin (GUA) enantiomers. In addition, an experimental design was used to optimize the gradient profile for the separation of racemic GUA and ambroxol HCl (AMB) binary mixture. The chromatographic method was achieved using Lux Cellulose-1 (50 × 4.6 mm) as a chiral stationary phase and ethanol/water as a mobile phase with linear gradient elution of 20% to 70% ethanol in 6 minutes at a flow rate of 1.0 mL min −1 and UV detection at 270 nm.Linearity ranges were found to be 50 to 1000 μg mL −1 and 15 to 450 μg mL −1 for each GUA enantiomer and AMB, respectively. Environmental, health and safety tool was used to assess and compare greenness of the proposed and reported methods. Short column indeed reduces the environmental impact by decreasing waste by about 60% and utilizing only 1-mL ethanol in the mobile phase. The proposed method is a safer alternative for the simultaneous determination of drugs in their combined pharmaceutical formulation. The method has been validated and compared favorably with a reported one.

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Section: Methodsmentioning

confidence: 96%

“…Aboul‐Enein et al have successfully developed a method for the separation of GUA enantiomers in pharmaceutical application with Ambroxol HCl (AMB) . This method was superior over other reported LC for determination of GUA enantiomers (Figure A) along with AMB (Figure B).…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50‐mm chiral column for a negligible environmental impact

2019

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“…Compare responses of the spike solutions and the neat standard solutions to assess the recovery from the sample preparation. In this stage, since only one particular step is being investigated (i.e., sample preparation), close to theoretical recovery should be observed at this point (e.g., 90-110%) [57].…”

Section: Sample Solvent Selectionmentioning

confidence: 59%

HPLC: Highly Accessible Instrument in Pharmaceutical Industry for Effective Method Development

Jena¹

2012

Pharm Anal Acta

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The analytical technique of High Performance Liquid Chromatography (HPLC) is used extensively thought the pharmaceutical industry. It allows simultaneously both qualitative and quantitative information of a drug. It is used to provide information on the composition of drug related samples. The information obtained may be qualitative, indicating what compounds are present in the sample. The information obtained may be qualitative, providing the actual amount of compounds in the sample. HPLC is used in all the different stages in the creation of new drug discoveries and also used routinely in the drug manufacturing process. The HPLC techniques is highly accessible to the author's knowledge this review represents the most exhaust description of instrumentation, method development, recent advancement, area of application. This article reviews the most recent advances in sample preparation, separation and the mass spectrometric aspects of high-throughput for method development.

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“…2) is 3-(2-methoxyphenoxy) propan-1, 2-diol. Literature survey revealed that spectrophotometric [14][15][16][17], HPTLC [18], and HPLC [19][20][21][22][23][24] analytical methods have been reported for GUA individually or in combination with other drug/s. Phenylephrine hydrochloride (PE) [25,26], a sympathomimetic agent (Fig.…”

Section: Introductionmentioning

confidence: 99%

Liquid Chromatography Tandem-Mass Spectrometry Method Development and Validation for Simultaneous Analysis of Paracetamol, Guaifenesin, Phenylephrine Hydrochloride, Chlorpheniramine Maleate, and Ambroxol Hydrochloride in Bulk and in Tablet Dosage Form

Potawale

Gilhotra

Gabhe

2018

Asian J Pharm Clin Res

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Objective: The objective is to study liquid chromatography tandem-mass spectrometry (LC/MS/MS) method for simultaneous quantification of paracetamol (PCM), guaifenesin (GUA), phenylephrine hydrochloride (PE), chlorpheniramine maleate (CPM), and ambroxol hydrochloride (AMB) in tablet dosage form developed and validated as per the International Conference on Harmonization Q2 (R1) guideline. Methods: The chromatograms were developed using a gradient mobile phase of WATER:methanol. Flow rate used was to 0.3 ml/min. Quantitation was performed using multiple reaction monitoring (MRM) mode to study parent to product ion transition, for paracetamol. (m/z 152.0 ≥ 110.0), guaifenesin (m/z 199.0 ≥163.0), phenylephrine hydrochloride (m/z 168.0≥ 150.0), chlorpheniramine maleate (m/z 275.0 ≥ 230.0) and ambroxol hydrochloride (m/z 379.0 ≥ 263.8). Results: The retention times were found to be 1.76, 1.81, 1.90, 2.10, and 2.33 min for PCM, GUA, PE, CPM, and AMB, respectively. The linearity of the method was found to be in the concentration range of 10–200 ng/ml for PCM, GUA, PE, CPM, and AMB. Percentage relative standard deviation values for repeatability and intermediate precision studies were below 2%. Conclusion: Developed method was found to be robust, precise, accurate, rapid and can be used to analyze fixed-dose tablet formulation used in the study.

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Simultaneous determination of Ambroxol Hydrochloride and Guaifenesin by HPLC, TLC-Spectrodensitometric and multivariate calibration methods in pure form and in Cough Cold Formulations

Cited by 16 publications

References 25 publications

Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50‐mm chiral column for a negligible environmental impact

Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50‐mm chiral column for a negligible environmental impact

HPLC: Highly Accessible Instrument in Pharmaceutical Industry for Effective Method Development

Liquid Chromatography Tandem-Mass Spectrometry Method Development and Validation for Simultaneous Analysis of Paracetamol, Guaifenesin, Phenylephrine Hydrochloride, Chlorpheniramine Maleate, and Ambroxol Hydrochloride in Bulk and in Tablet Dosage Form

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