DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CINNARIZINE AND DIMENHYDRINATE IN TABLET DOSAGE FORM
AbstractA 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.
Article Information
23
4815-4819
418KB
2190
English
IJPSR
S. Khushbu and P. Pinkal
Department of Quality Assurance Parul Institute of Pharmacy and Research, Parul Trust Limda, Ta. Waghodia, Dist. Vadodara 391760, Gujarat, India.
Soni.khushbu50@gmail.com
19 April, 2014
03 July, 2014
31 July, 2014
http://dx.doi.org/10.13040/IJPSR.0975-8232.5(11).4815-19
01 November, 2014