RP-HPLC METHOD FOR THE SIMULTANEOUS ANALYSIS OF CODEINE AND CHLORPHENIRAMINE MALEATE IN ITS TABLET DOSAGE FORM

Abstract

The present research focuses on simultaneous estimation of Codeine and Chlorpheniramine maleate in its tablet dosage form by using Reverse Phase – High Performance Liquid Chromatography (RP-HPLC). Literature review reveals that HPLC and HPTLC are the reported analytical methods for compounds either individually or in combination with other dosage form. Hence present work is aimed to develop a new, simple, fast, accurate, efficient and reproducible RP-HPLC method for the simultaneous analysis of Codeine and Chlorpheniramine maleate and validated according to ICH guidelines. Both the drugs are simultaneously assayed and validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The chromatographic conditions were success fully developed for the separation of Chlorpheniramine and Codeine by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoric acid) with detection wavelength 252nm. The linearity study of Chlorpheniramine and Codeine was found in concentration range of 5µg25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999. % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19, LOD with 3.17 and 5.68, LOQ with 0.0172 and 0.2125 respectively. Hence the above RP-HPLC method can be used for routine analysis of Codeine and Chlorpheniramine in API and Pharmaceutical dosage form.