Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF ANTI- EPILEPTIC DRUG BRIVARACETAM IN BULK DRUG PHARMACEUTICAL FORMULATION

Himanshu Arora, Dr. Rajiv K. Tonk*, Dr. Meenakshi Dahiya, Dr. Rajeev Singh Raghuvanshi, Suryadev Sharma*, Dr. Robin Kumar

ABSTRACT

The aim of present research work is to develop stability indicating validated RP-HPLC method for the determination of Anti-Epileptic drug “Brivaracetam” in Pharmaceutical bulk form. A Simple, Economic, Accurate, Sensitive and Precise RP-HPLC method was developed for Anti- Epileptic drug Brivaracetam. The method was developed by using Inertsil C8 (150mm×4.5mm, 5μm) column and the Mobile phase composed of Methanol: HPLC grade Water in ratio 50:50 v/v and pH was adjusted to 3.5 with Ortho-phosphoric acid. Add 1 ml Perchloric acid in it. The Retention time for Brivaracetam was found to be 6.16 min. Linearity range for Brivaracetam was found to be 80-120 μg/ml and the Regression equation was found to be y=14254x + 69378 . The value of Linearity regression coefficient was found to be R 2 = 0.996. % RSD for inter and intra-day precision was found to be 0.22% and 0.72%. LOD and LOQ values obtained for Brivaracetam were found to be 37.1641 μg/ml and 112.618 μg/ml respectively. The result are analysed statistically and are found to be satisfactory. Hence this method can be successfully employed for analysis of AntiEpileptic drug Brivaracetam in Bulk form.

Keywords: Brivaracetam, RP-HPLC, %RSD, PPM.