Bioanalytical Method Development by LC-MS/MS and Liquid Chromatographic Techniques for the Assay and Validation of Olaparib

Author(s): Y. Ashwini, N. Venkatesan* and B.R. Avinder

Abstract

The present method was developed for the estimation of Olaparib in spiked human plasma using Liquid chromatography-mass spectroscopy. The liquid-liquid extraction method was adopted and chromatographic separation was performed on a waters symmetry shield, C18 (4.6 mm id x 50 mm) analytical column using (Acetonitrile: Ammonium bicarbonate, pH 4.2 in the volume ratio of 70:30) as mobile phase. Positive ion mode was selected to obtain the product m/z+515.200 (parent)→380.3 (product) for Olaparib and m/z+435.22 (parent)→322.700 (product) for internal standard. Calibration curve was linear over the range of 3 ng/ml-600 ng/ml. The intra and interday accuracy with % nominal 95→98.4%, precision %CV ≤ 2% in all quality control levels, The percentage extraction recovery (96.15%→98.34%), demonstrated excellent matrix and analyte selectivity (% interference=0), and satisfactory stability study results in all types (% nominal 93.91%→99.58%). Based on the experimental findings the current developed method was considered a novel validated bioanalytical method, and applied in blood samples for bioanalytical studies of marketed formulations.

image 10.4303/JDAR/236414

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