Abstract

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

Mohammed Asif Adnan* and Chandrashekar Javali

ABSTRACT

A simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for simultaneous estimation of Dimethyl Fumarate and Dimenhydrinate. Chromatography was performed on a Lichrospher® 100, C8(250 mm×4.6 mm, 5μ) column using Methanol : 1% Triethylamine (40 : 60) as a mobile phase. The detection was carried out at 265 nm with a flow rate of 0.8 mL/min. The retention times were 4.3 and 5.8 minutes for Dimethyl Fumarate and Dimenhydrinate, respectively. Proposed method was validated as per ICH guidelines for linearity, accuracy, precision; specificity and robustness for estimation of Dimethyl Fumarate and Dimenhydrinate and results were found to be satisfactory. The linearity of the method was excellent over a concentration range 20-100μg/mL for Dimethyl Fumarate and 40-200μg/mL for Dimenhydrinate. The correlation coefficient was 0.9996 and 0.9992 for Dimethyl Fumarate and Dimenhydrinate, respectively. The limit of detection was 1.62μg/mL and 2.62μg/mL for Dimethyl Fumarate and Dimenhydrinate, respectively. The limit of quantitation was 4.93μg/mL and 7.95μg/mL for Dimethyl Fumarate 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 Dimethyl Fumarate and Dimenhydrinate.

Keywords: Dimethyl Fumarate, Dimenhydrinate RP-HPLC method, Validation.