DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CINNARIZINE AND DIMENHYDRINATE IN TABLET DOSAGE FORM

A simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for simultaneous estimation of Cinnarizine and Dimenhydrinate in Tablet Dosage Form. Chromatography was performed on a PhenomenexPartisil ODS C₁₈ (250 X 4.6 mm) 5mm column using Acetonitrile: Water (90:10) as a mobile phase. The detection of the synthetic mixture was carried out at 265 nm with a flow rate of 0.7 ml/min. The retention times were 4.3 and 5.8 minutes for Cinnarizine and Dimenhydrinate, respectively. Proposed method was validated as per ICH guidelines for linearity, accuracy, precision; specificity and robustness for estimation of Cinnarizine and Dimenhydrinate in Tablet Dosage Form and results were found to be satisfactory. The linearity of the method was excellent over a concentration range 20-100μg/ml for Cinnarizine and 40-200μg/ml for Dimenhydrinate. The correlation coefficient was 0.996 and 0.992 for Cinnarizine and Dimenhydrinate, respectively. The limit of detection was 1.62μg/mL and 2.62μg/mL for Cinnarizine and Dimenhydrinate, respectively. The limit of quantitation was 4.93μg/mL and 7.95μg/ml for Cinnarizine and Dimenhydrinate, respectively. The relative standard deviation values for repeatability, intraday precision and interday precision studies were less than 2 % and % recovery was 98 % to 102 % for both drugs. So the proposed method was found to be suitable for the routine estimation of Cinnarizine and Dimenhydrinate in Tablet Dosage Form.