Development and Validation of Analytical Method for Bromhexine Hydrochloride, Chlorpheniramine Maleate and Guaifenesin by Simultaneous Equation Spectroscopic Method

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Bromhexine hydrochloride, Chlorpheniramine maleate and Guaifenesin in syrup using simultaneous equation Method. In this spectroscopic method, 249.00 nm and 261.00 nm and 274.00 nm wavelengths respectively were selected for measurement of slope and intercept according to its calibration curves. Bromhexine, Chlorpheniramine maleate and Guaifenesin show linearity in a concentration range of 02–10μg/ml, 01–05μg/ml and 25–125μg/ml at their respective λ max. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.102μg/ml, 0.169μg/ml and 0.312μg/ml for Bromhexine, chlorpheniramine maleate and guaifenesin respectively. The limit of quantification was 0.311μg/ml, 0.947μg/ml and 0.514μg/ml for Bromhexine, chlorpheniramine maleate and guaifenesin respectively. Recovery of Bromhexine, guaifenesin and chlorpheniramine maleate were found to be 100.02%, 101.17 and 100.66% respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.