Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF DIMETHYL FUMARATE AND ONDANSETRON

Mohammed Asif Adnan* and Chandrashekhar Javali

ABSTRACT

A simple, sensitive, precise rapid and accurate reverse phase high performance liquid chromatography (RP- HPLC) method was developed and validated for simultaneous estimation of Dimethyl Fumarate and Ondansetron. The Chromatographic separation was achieved by using Lichrospher® 100, C18(250 mm×4.6 mm, 5μ) as stationary phase and mobile phase consists of Methanol: Acetonitrile: phosphate buffer with pH 5.5 (50:20:30 v/v/v) with a flow rate of 1ml/min. The analysis was performed at ambient temperature and the eluent was monitored at 239nm using UV detector. The retention time of Dimethyl Fumarate & Ondansetron was found to be 3.1min and 6.9 min respectively and the calibration curves were linear (r2 = 0.9998 and 0.9997) over a concentration range of 100-1000μg/ml for Dimethyl Fumarate & Ondansetron respectively. The Limit of detection (LOD) for Dimethyl Fumarate & Ondansetron was observed to be 0.1μg/ml and 0.4μg/ml respectively, the limit of quantitation (LOQ) was found to be 0.4μg/ml and 0.8μg/ml respectively. The developed method was validated as per ICH guidelines using parameters like linearity, specificity, system suitability, precision, ruggedness, robustness, accuracy. All the validation parameters were found to be well within the acceptance criteria. Hence the proposed method can be used for the routine analysis of Dimethyl Fumarate and Ondansetron in bulk and tablet dosage forms.

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