Analytical Method Development and Validation of Related Substance Method for Bortezomib for Injection 3.5 mg/Vial by RP-HPLC Method

An accurate, precise, simple and economical High Performance Liquid Chromatographic method for therelated substance determination of Bortezomib in its lyophilized dosage form has been developed. Themethod developed is Reverse Phase High Performance Liquid Chromatographic method using HypersilBDS C18 column (Length: 150mm, Diameter: 4.6mm, Particle size: 5μ) with Gradient programmed anda simple Acetonitrile, Water and Formic acid in the ratio of 30:70:0.1 (v/v/v) respectively as mobilephase A and Acetonitrile, Water and Formic acid in the ratio of 80:20:0.1 (v/v/v) respectively. Themethod so developed was validated in compliance with the regulatory guidelines by using welldeveloped analytical method validation tool which comprises with the analytical method validationparameters like Linearity, Accuracy, Method precision, Specificity with forced degradation, Systemsuitability, Robustness, LOD, LOQ and Ruggedness. The results obtained were well within theacceptance criteria.