RP-HPLC FOR THE SIMULTANEOUS DETERMINATION OF CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN PHARMACEUTICAL PREPARATION

Abstract

Objective: The present study aimed to develop and validate a novel, simple, rapid, and precise RP-HPLC (Reverse-Phase High-Performance Liquid Chromatography) method for the simultaneous estimation of Chlorpheniramine Maleate (CPM) and Dextromethorphan Hydrobromide (DXM) in combined pharmaceutical dosage forms. Methods: Using an isocratic mobile phase composed of Phosphate Buffer (pH 6.2): Acetonitrile: Methanol in the ratio of 35:34:31 (v/v), a Spherisorb 5µ CN column (250 mm x 4.6 mm) was used to optimize chromatographic separation. The flow rate was 1.5 mL/min. The column temperature throughout runs was held at 40°C and detection used 228 nm with an injection volume of 20 µL. The method was validated comprehensively according to general ICH Q2(R1) guidelines for the outtake of specificity, linearity, accuracy and precision. Results: The method was capable of providing sharp, well-resolved peaks for CPM and DXM at retention times of 6.53 min and 8.18 min, respectively. The method showed excellent linearity in the range of 80-120% of the test concentration for both drugs. Correlation coefficients (r²) were 0.9995 for CPM and 0.9998 for DXM. The accuracy, determined by recovery studies, was mean recoveries of 98.96-101.16% for CPM and 95.87-98.06% for DXM. The method was precise with %RSD for repeatability and intermediate precision both being less than 1% of that measured (1.9-0.39% respectively) for both analytes. Robustness studies confirmed that the method remained unaffected by minor, intentional variations in chromatographic parameters. Conclusion: The present RP-HPLC method is simple, accurate, precise, robust, and specific. It provides a means for simple simultaneous determination of CPM and DXM in combined pharmaceutical formulations. It is an ideal method for routine quality control and KNP analysis of all pharmaceutical formulas containing Chlorpheniramine Maleate and Dextromethorphan Hydrobromide.