2564-7814

Validation of an HPLC Method for Accurate Quantification of Impurities in Brivaracetam to Ensure Drug Quality and Safety

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1Karumuru Durga Vara Prasad Reddy, 2Dr. Harbeer Singh

Abstract

Brivaracetam (BRV) represents a significant advancement in the treatment of epilepsy, offering improved efficacy and safety over traditional antiepileptic drugs (AEDs). Despite these benefits, the presence of impurities in BRV formulations can impact drug quality and patient safety. This study presents the development and validation of a high-performance liquid chromatography (HPLC) method for the accurate quantification of key impurities in BRV. Specifically, the method targets impurities such as (R)-2-((R)-2-oxo-4-propylpyrrolidin-1-yl)butanamide and (S)- 2-((S)-2-oxo-4-propylpyrrolidin-1-yl)butanamide. The method's robustness and sensitivity are validated in accordance with International Council for Harmonization (ICH) guidelines. This analytical approach ensures the high purity of BRV, contributing to its efficacy and safety profile and supporting its continued clinical use.

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