ABSTRACT

The current study focuses on developing a simple, precise and accurate RP-HPLC method for simultaneous analysis of Bromhexine hydrochloride, Guaiphenesin and Chlorpheniramine maleate in bulk and combined dosage forms. The chromatographic conditions were standardized using Hypersil BDS column (150×4.6mm, particle size 5?) with UV detection at 225nm and mobile phase consist of 0.01M potassium dihydrogen phosphate buffer (pH adjusted to 3 with 1% ortho phosphoric acid): acetonitrile: methanol (45:5:50 v/v/v) with flow rate 0.8mL/min. The injection volume was 10?L and run time was about 10 minutes. The retention times of Guaiphenesin, Chlorpheniramine maleate and Bromhexine hydrochloride have been found to be 2.861 min, 4.050 min and 7.273 min respectively. The calibration curves were linear with a correlation coefficient of 0.9994, 0.9992 and 0.9992 over a concentration range of 5.0?g/mL-25.0?g/mL for Bromhexine hydrochloride, 10.0?g/mL-50.0?g/mL for Guaiphenesin and 5.0?g/mL-25.0?g/mL for Chlorpheniramine maleate respectively. Method was accurate with % recovery of 99.88%, 100.17% and 99.59% and for Bromhexine hydrochloride, Guaiphenesin and Chlorpheniramine maleate. The method was evaluated for validation parameters such as specificity, linearity, precision, accuracy, limit of detection and quantification and robustness according to International Conference on Harmonization (ICH) Q2R1 guidelines. Keywords: Guaiphenesin, Chlorpheniramine maleate, Bromhexine hydrochloride, ICH, RP-HPLC
Publication date: 01/05/2023

https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7106.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2023/12.5.7106