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.
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Acknowledgments
The authors wish to thank the management of Dr. Reddy’s group for supporting this work. The authors wish to acknowledge the Process research group for providing samples for our research. We would also like to thank colleagues in the Separation Science Division of Analytical Research of High Potent Active Pharmaceutical Ingredients for their co-operation in carrying out this work.
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Saravanan, G., Rao, B.M., Ravikumar, M. et al. Development of an HPLC Assay Method for Lenalidomide. Chroma 66, 287–290 (2007). https://doi.org/10.1365/s10337-007-0290-y
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DOI: https://doi.org/10.1365/s10337-007-0290-y