Abstract

METHOD DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE DETERMINATION OF BRIVARACETAM IN THE BULK AND PHARMACEUTICAL DOSAGE FORM

Nikhil S.*, Harsha K. Tripathy, Chandanam Sreedhar and T. Srinivasa Rao

ABSTRACT

The aim of the work is to develop new and sensitive method for estimation of brivaracetam by RP-HPLC method. There is very few methods as done on brivaracetam from hplc method, which aimed us to develop a method by hplc. The chromatographic conditions was developed for separation of brivaracetam by using water’s Xbridge C18 column of particle size 5μ250 x 4.6mm, flow rate was 1.0ml, Mobile phase ratio was phosphate buffer: acetonitrile (65:35% v/v), detection wavelength 215nm. Mannul injecting hplc and injection volume 20μl with 10min of run time, The retention time was found to be 4.610 min. The method was validated according to ICH guidelines parameters like accuracy, precision, linearity, limit of detection (LOD) and limit of quantification (LOQ). Shows good Linearity with r2=0.9980 of 10-60μl/min and LOQ and LOD were found to be 7.945 and 2.383 μl/ml respectively.

Keywords: Brivaracetam, RP-HPLC, Accuracy, Precision, linearity, LOD, LOQ.