A stability indicating RP-HPLC method for the determination of bendamustine HCL in parenterals..

Author(s): Vasanth P. M.

Abstract

A simple, precise, accurate, economical and reproducible HPLC method for estimation of Bendamustine HCl in Parenteral dosage form has been developed. Quantitative HPLC was performed with AGILENT 1120 COMPACT LC HPLC with software EZ CHROME ELITE with UV-Visible detector). Agilent Zorbax poroshell 120EC –C18 RP column, 100 x 4.6 mm, 2.7mm was used in the study. The mobile phase of water and Acetonitrile (with 0.01% TFA) were mixed in the ratio of 50:50 of pH 6.9-7.2 were used in this study. The conditions optimized were: flow rate (0.5 mL/minute), wavelength (254 nm) and run time was 10 min. Retention time was found to be 2.720 min. The linearity was found to be in the concentration range of 80-120% of target concentration. The developed method was evaluated in the assay of commercially available vial Bendit/Purplz label to contain Bendamustine HCl 100mg/vial strength. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug.

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