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

Author(s)

Utage, M., Swamy, B. M. V.

Author's Affiliation

Abstract

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

Keywords

Bortezomib, HPLC, Hypersil BDS

Cite This Article

Utage, M., Swamy, B. M. V. (2013). Analytical Method Development and Validation of Related Substance Method for Bortezomib for Injection 3.5 mg/Vial by RP-HPLC Method. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 27-32.