Development of an HPLC Assay Method for Lenalidomide |
| |
| Authors: | G Saravanan B M Rao M Ravikumar M V Suryanarayana N Someswararao P V R Acharyulu |
| |
| Institution: | (1) Analytical Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories, Hyderabad, 500072, India;(2) Analytical Research, Custom Pharmaceutical Services, DR. Reddy’s Laboratories, Hyderabad, 500049, India;(3) Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapattanam, 530 003, India;(4) Process Research, High Potent Active Pharmaceutical Ingredients Operations, DR. Reddy’s Laboratories, Hyderabad, 500072, India |
| |
| 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 |
| 本文献已被 SpringerLink 等数据库收录！ |
|
