Development and validation of Novel Spectro-chemometric and high performance liquid chromatography methods for simultaneous determination of binary mixture of etilefrine hydrochloride and chlorpheniramine maleate in their bulk powders and different pharmaceutical formulations

Abstract

Simple, sensitive and reliable spectro-chemometric and high performance liquid chromatography (HPLC) methods were developed for simultaneous determination of binary mixture of etilefrine hydrochloride and chlorpheniramine maleate without prior separation in their bulk drugs and dosage forms. The spectro-chemometric methods used are, derivative spectrophotometry, derivative ratio, and isosbestic point methods. The HPLC method involves the use of reversed-phase separation mode using eluant of pH 3.5, consisted of phosphate buffer/acetonitrile (30:70 v/v) and Zorbax ODS column. All variables influencing the spectrophotometric and HPLC methods were carefully investigated and optimized. The developed methods were evaluated according to United State Pharmacopeia (USP) and International Conference of Harmonization (ICH) rules. The current methods were successfully implemented for direct the determination of these drugs in their trade pharmaceutical formulations. The obtained results were contrasted with those calculated after application of reference method. The data obtained from both methods were statistically analyzed by F- and t-tests. The results of such study showed excellent agreement in respect to the accuracy and precision of the suggested and reference methods.