Chromatographia

, Volume 66, Issue 3, pp 287–290

Development of an HPLC Assay Method for Lenalidomide

Authors

  • G. Saravanan
    • Analytical Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s Laboratories
    • Analytical Research, Custom Pharmaceutical ServicesDR. Reddy’s Laboratories
  • M. Ravikumar
    • Analytical Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s Laboratories
  • M. V. Suryanarayana
    • Analytical Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s Laboratories
  • N. Someswararao
    • Department of Inorganic and Analytical ChemistryAndhra University
  • P. V. R. Acharyulu
    • Process Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s Laboratories
Limited Short Communication

DOI: 10.1365/s10337-007-0290-y

Cite this article as:
Saravanan, G., Rao, B.M., Ravikumar, M. et al. Chroma (2007) 66: 287. doi:10.1365/s10337-007-0290-y

Abstract

Chromatographic separation of lenalidomide and its impurities was achieved on an Inertsil ODS-3 V column using a mobile phase consisting of a mixture of buffer, acetonitrile and methanol in the ratio 80:8:12 v/v. Degradation studies were performed on bulk samples of lenalidomide subjected to 0.5 N hydrochloric acid, 0.5 N sodium hydroxide, 10% v/v hydrogen peroxide, heating to 60 °C and UV light at 254 nm. Degradation was observed only under base hydrolysis conditions. The developed LC method gave a mass balance close to 99.5%, proving it to be suitable for stability studies and was validated with respect to linearity, accuracy, precision and robustness.

Keywords

Column liquid chromatographySolution and mobile phase stabilityDegradation studiesLenalidomide

Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2007