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

Author(s): Utage M | Dr. Swamy BMV

Journal: International Journal For Pharmaceutical Research Scholars
ISSN 2277-7873

Volume: 2;
Issue: 2;
Start page: 93;
Date: 2013;
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Keywords: Bortezomib | HPLC | Hypersil BDS

An accurate, precise, simple and economical High Performance Liquid Chromatographic method for theEstimation of Bortezomib in its lyophilized dosage form has been developed. The method developed isReverse 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 Acetonitrilemixed in the proportion of 20:80v/v as a mobile phase, and Methanol: Water (90:10) as a diluent. 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 and Ruggedness. The results obtained were well within the acceptance criteria.
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