Abstract
The aim of this study is to create and validate a fast, easy-to-use, affordable, sensitive, and accurate method for measuring Venetoclax and Obinutuzumab in bulk and pharmaceutical products using Normal-Phase High-Performance Liquid Chromatography (NP-HPLC). Hypersil chiral column was used with a running phase composed of Methanol: n-Hexane: 0.1% Formic acid (60:20:20 v/v) at a flow rate of 1.0 ml/min. UV detection was used at a wavelength of 225 nm. Obinutuzumab and Venetoclax correlation coefficients were found to be 0.999 over a concentration range of 6.25-37.5 µg/ml and 2.5-15 µg/ml, respectively. Venetoclax and Obinutuzumab have respective retention times of 3.134 and 6.929 minutes. The run time for separating Obinutuzumab and Venetoclax peaks was 10 minutes. This method, proposed as a regular analysis and quality control tool for medications that contain these active drugs either individually or in combinatio, was evident to be a suitable one. Keywords: HPLC, Obinutuzumab, Venetoclax, Development, Validation
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