Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF VARENICLINE TARTRATE AND BUPROPION HYDROCHLORIDE

Poornesh Gowda A. S.*, Chandrashekhar Javali and Nandakumar R.

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 Varenicline tartrate and Bupropion hydrochloride. The Chromatographic separation was achieved by using Cosmosil C18 (250 mm×4.6 mm, 5μ) as stationary phase and mobile phase consists of Methanol: phosphate buffer with pH 3.0 (65:35 v/v) with a flow rate of 1ml/min. The analysis was performed at ambient temperature and the eluent was monitored at 244 nm using UV detector. The retention time of Varenicline tartrate and Bupropion hydrochloride was found to be 3.0 min and 4.2 min respectively and the calibration curves were linear (r2 = 0.999 and 0.998) over a concentration range of 10-50μg/ml for Varenicline tartrate and 100-500 μg/ml for Bupropion hydrochloride respectively. The Limit of detection (LOD) for Varenicline tartrate and Bupropion hydrochloride was observed to be 0.002μg/ml and 0.006μg/ml respectively, the limit of quantitation (LOQ) was found to be 0.006μg/ml and 0.018μg/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 Varenicline tartrate and Bupropion hydrochloride in bulk and tablet dosage forms.

Keywords: Varenicline tartrate, Bupropion hydrochloride, RP-HPLC, Simultaneous estimation. ICH guidelines.