Stability Indicating HPLC Method Development and Validation for Thalidomide and its Impurity Determination

A simple, accurate, precise, stability indicating HPLC method was carried for the determination of thalidomide along with its impurities. An HPLC isocratic separation was achieved on Develosil ODS UG-5 column (150mm X 4.6 mm X 5um particle size) with a mobile phase 0.01M potassium dihydrogen orthophosphate and Acetonitrile in the ratio of 80:20 (v/v) 1.02gm in 500 ml. The flow rate was set at 0.700ml with a detection wavelength of 297nm. The linearity range of thalidomide and its impurities were 0.99914, 0.99966 and 0.99968 respectively. The drug undergoes degradation under acid, base, H₂O₂, thermal and humidity conditions. The method was validated for precision, accuracy, ruggedness and robustness as per ICH guidelines.