DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF LENALIDOMIDE AND ITS IMPURITIES IN SOLID DOSAGE FORM

Abstract

Highly sensitive RP-HPLC method has been developed for the determination and quantification of Lenalidomide
impurities in Lenalidomide liquid dosage formulations. Samples are analysed by means of reverse phase (RP-HPLC) using
stationary phase an Inertsil ODS-3V (150 x 4.6 mm, 3μm) and the mobile phase consists of two channels A and B;
channel-A: pH 3.0 phosphate buffer and channel-B: Acetonitrile: water (90:10 v/v). The flow rate was 1.0 mL/min.
The column temperature was maintained at 40°C and sample cooler temperature was maintained at 5°C, injection
volume 20 μL and wavelength 210 nm. The developed HPLC method was validated with respect to specificity,
precision, linearity, accuracy, solution stability and filter study. Validation study was compared as per ICH guideline.