Development of an HPLC Assay Method for Lenalidomide
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- Saravanan, G., Rao, B.M., Ravikumar, M. et al. Chroma (2007) 66: 287. doi:10.1365/s10337-007-0290-y
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.