Limited Short Communication

Chromatographia

, Volume 66, Issue 3, pp 287-290

First online:

Development of an HPLC Assay Method for Lenalidomide

  • G. SaravananAffiliated withAnalytical Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories
  • , B. M. RaoAffiliated withAnalytical Research, Custom Pharmaceutical Services, DR. Reddy’s Laboratories Email author 
  • , M. RavikumarAffiliated withAnalytical Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories
  • , M. V. SuryanarayanaAffiliated withAnalytical Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories
  • , N. SomeswararaoAffiliated withDepartment of Inorganic and Analytical Chemistry, Andhra University
  • , P. V. R. AcharyuluAffiliated withProcess Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories

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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 chromatography Solution and mobile phase stability Degradation studies Lenalidomide