Stability Indicating HPLC Method for Estimation of Bortezomib for Injection 3.5 mg/Vial

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 Estimation 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: 150 mm, Diameter: 4.6mm, Particle size: 5μ) with a simple 0.1 % TFA buffer and Acetonitrile mixed in the proportion of 20:80v/v as a mobile phase, and Methanol: Water (90:10) as a diluent. 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 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). Stability Indicating HPLC Method for Estimation of Bortezomib for Injection 3.5 mg/Vial. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 93-98.