Analytical Method Development and Validation of RP-HPLC Method for Estimation of Venetoclax in Pharmaceutical Dosage Form

Abstract: A simple and new isocratic high-performance liquid chromatography (HPLC) method was developed for the quantitative determination of Venetoclax in its tablet dosage form. The chromatographic separation was achieved on Perkin C8 (15cm x 4.6mm id, 5µ) column. The mobile phase selected was buffer (25 mm ammonium acetate) adjusted to pH 3.0 with orthophosphoric acid and acetonitrile in the ratio of (55:45) v/v at a flow rate of 0.7ml/min with column temperature maintained at 400C and 10µl injection volume. The detection was carried out at 286nm by a UV-visible detector. The retention time of Venetoclax was found to be 4.19 minutes. The proposed method was linear over the range of 5-50µg/ml with a correlation coefficient (R2) of 0.9998. The limits of detection and quantification values were found to be 0.53µg/ml and 1.62µg/ml respectively. All validation parameters were within the limits as per the ICH guidelines. The results of validation parameters indicate that the developed HPLC method was specific, accurate, precise, rapid, reliable and reproducible, therefore it can be applied for routine quality control analysis of Venetoclax in its tablet dosage form.