DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF VENETOCLAX AND OBINUTUZUMAB IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, sensitive and rapid chromatographic method was developed and validated for quantification of Venetoclax and Obinutuzumab in bulk and pharmaceutical dosage form using Cliral cell ODH (4.6x150mm, 5μ) column. The mobile phase consists of isopropyl alcohol, n-hexane and tetra hydrofuran with 1ml of acetic acid in the ratio of 50:30:20v/v/v. The flow rate is maintained at 1.0 ml/min, detection was carried out by absorption at 221nm using photo diode array detector. The calibration curve was linear and regression coefficient (R2) value was found to be 0.999 and concentration ranging from 3-45 μg/ml of Venetoclax and 0.75-11.25 μg/ml of Obinutuzumab respectively. The LOD and LOQ of the method were found to be 0.03 μg/ml, 0.0075μg/ml and 0.3μg/ml, 0.075μg/ml for Venetoclax and Obinutuzumab. The developed method was found to be simple, economical, suitable and validated according to ICH guidelines.