Chromatographia

, Volume 66, Issue 3, pp 287–290

Development of an HPLC Assay Method for Lenalidomide

  • G. Saravanan
  • B. M. Rao
  • M. Ravikumar
  • M. V. Suryanarayana
  • N. Someswararao
  • P. V. R. Acharyulu
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

Authors and Affiliations

  • G. Saravanan
    • 1
  • B. M. Rao
    • 2
  • M. Ravikumar
    • 1
  • M. V. Suryanarayana
    • 1
  • N. Someswararao
    • 3
  • P. V. R. Acharyulu
    • 4
  1. 1.Analytical Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s LaboratoriesHyderabadIndia
  2. 2.Analytical Research, Custom Pharmaceutical ServicesDR. Reddy’s LaboratoriesHyderabadIndia
  3. 3.Department of Inorganic and Analytical ChemistryAndhra UniversityVisakhapattanamIndia
  4. 4.Process Research, High Potent Active Pharmaceutical Ingredients OperationsDR. Reddy’s LaboratoriesHyderabadIndia