Abstract

METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF OLAPARIB IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Priyanka Waje*, Preeti Kulkarni, Smita George, Vijaya Kumar Munipalli, Raman Mohan Singh and Bhaskar Vaidhun

.

Abstract

A simple and new isocratic high-performance liquid chromatography (HPLC) method was developed for quantitative determination of Olaparib in its tablet dosage form. The chromatographic separation was achieved on Thermo Scientific C18 column (250mm x 4.6mm i.d.5μ). The mobile phase selected was 0.1% Trifluoroacetic buffer: Acetonitrile in the ratio of 60: 40 v/v at flow rate 1.0ml/min with column temperature maintained at 35°C and 10μl injection volume. The detection was carried out at 276nm. The retention time of Olaparib was found to be at 5.14 min. The developed HPLC method was validated as per ICH (Q2R1) guideline. The HPLC method was linear over range of 25-75 μg/ml with regression coefficient 0.9991. The results of validation parameters indicate that developed HPLC method was specific, accurate, precise, rapid, reliable and reproducible therefore, it can be applied for routine quality control analysis of Olaparib in its tablet dosage form.

Keywords: RP-HPLC, Olaparib, Method Development, Validation, ICH guidelines.