Abstract

A QbD APPROACH TO THE METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF BENDAMUSTINE HYDROCHLORIDE IN BULK BY RP-HPLC

D. Sushma* and S. Y. Manjunath

ABSTRACT

This work presents a simple and fast method for the estimation of Bendamustine HCl by RP HPLC method. Methanol and 0.1% phosphoric acid were used as diluents. Subsequently samples were evaluated directly by using Phenomenex C18 (150mm X 4.6mm, 5μm) column by isocratic run by using Methanol and 0.1% phosphoric acid (50:50) as mobile phase with flow rate 1ml/min.The determination of Bendamustine HCl was carried out at 233nm wavelength. The method was validated according to ICH (International Conference on Harmonization) guidelines with respect to Specificity, Precision (System and Method), Ruggedness, Linearity (Linearity range 1-10mg/ml,R 2 =0.999), and Accuracy. All the parameters examined were found to be well within the stated guidelines. The present method can be used for the routine analysis.

Keywords: Bendamustine HCl, RP-HPLC, Methanol, Water, 0.1% phosphoric acid, ICH.