COMPARATIVE STUDY OF LEVETIRACETAM IN- VITRO DRUG RELEASE IN VARIOUS BRANDS OF PR TABLETS BY RP-HPLC

Ashwani Kumar*, Dr. Gaurav Pratap Singh Jadaunb, Dr. Meenakshi Dahiyac, Anirudha Malikd, Nidhi Jain and Dr. Babita Kumar

ABSTRACT

This research aims to assess and compare the in vitro drug release profiles of various brands of Levetiracetam prolonged release tablets utilizing reverse phase high-performance liquid chromatography (RP-HPLC). Levetiracetam PR tablets from different manufacturers were selected for in vitro drug release studies conducted in phosphate buffer at pH 6.0, with a mobile phase consisting of 10:90 acetonitrile and buffer. The released drug was collected, separated through chromatography, and detected using RP-HPLC. The drug release rates were calculated and compared among the different brands purchased from the market. The findings indicated a significant variation in drug release rates among the various brands of levetiracetam PR tablets, with some brands falling below the limits set by the USP monograph for controlled drug release, while others exceeded these limits. This study underscores the critical role of in vitro drug release testing in ensuring therapeutic equivalence. The results suggest that not all brands demonstrate similar drug release profiles, which may influence therapeutic efficacy and safety. RP-HPLC serves as a sensitive and selective method for comparing drug release from prolonged release formulations, thereby supporting formulation development and quality control.

Keywords: This study underscores the critical role of in vitro drug release testing in ensuring therapeutic equivalence.