ABSTRACT

A simple and rapid high-performance liquid chromatographic method for the determination of an anti-epileptic drug Brivaracetam in human plasma has been developed, optimized, and validated, with an azole anti-fungal Fluconazole as the internal standard (I.S). A protein precipitation technique was used for plasma sample pre-treatment before injection into the HPLC system with a UV detector. The mobile phase consisted of Phosphate Buffer (0.05M, pH=5) and Acetonitrile in the ratio of 70:30 v/v. The detection wavelength chosen was 220 nm. The method was found to be linear over the concentration range of 1-8 ?g/mL. It was validated as per ICH M10 guidelines for the parameter’s selectivity, specificity, linearity, accuracy, precision, stability, carry-over, recovery, and matrix effect. The stability of Brivaracetam in plasma was studied in terms of bench- top stability, freeze-thaw stability, and long-term stability. The results were found to be within the acceptable limits stated by ICH. The developed method can be applied during clinical trials, therapeutic drug monitoring in human plasma and bio-equivalence studies. Keywords: Brivaracetam, Fluconazole, HPLC, human plasma, bioanalytical, validation
Publication date: 01/06/2024

https://ijbpas.com/pdf/2024/June/MS_IJBPAS_2024_8096.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.6.8096