Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYTICAL DETERMINATION OF ISOMERIC IMPURITIES IN BRIVARACETAM BY RP-HPLC METHOD

Divya Pingili*, Bathula Neha, Archana Awasthi, P. Venkateswara Rao, Pingali Sridevi

ABSTRACT

Background: Brivaracetam is a novel antiepileptic drug that requires precise and reliable analytical methods for quantification and impurity profiling in pharmaceutical formulations. A validated method is essential to ensure product quality, stability, and regulatory compliance. Methods: A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Brivaracetam and its related impurities. The study utilized Brivaracetam, KH₂PO₄, HPLC-grade water, methanol, acetonitrile, and orthophosphoric acid. Analytical work was carried out using a WATERS 2690 HPLC system, with optimized chromatographic conditions to achieve effective separation. System suitability test parameters, including resolution, theoretical plates, and tailing factor, were assessed. The method was validated in accordance with ICH guidelines for linearity, accuracy, precision, robustness, limitof detection (LOD), and limit of quantification (LOQ). Results: The developed method demonstrated excellent linearity with a correlation coefficient (R²) of 0.999. Accuracy was established with recovery values between 97–103%. Precision studies confirmed reproducibility with %RSD within acceptable limits. The method was sensitive with well-defined LOD and LOQ values. Robustness studies indicated that minor changes in flow rateand mobile phase composition did not affect system performance. Conclusion: The validatedRP-HPLC method is accurate, precise, robust, and suitable for the routine analysis ofBrivaracetam and its impurities in pharmaceutical formulations.

Keywords: Brivaracetam, RP-HPLC, ICH guidelines, Validation, Impurity profiling.