Novel Method Development and Validation for The Quantitative Estimation of Lenalidomide in Api Form and Marketed Capsule Dosage Form by Using RP-HPLC (Research Article)

Author(s): E. Nikhil Chakravarthy*, Rhaghava Sai, Ch. Sapnika, Karadi Sravani, V Mahesh

Abstract: A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Lenalidomide in bulk form and marketed formulation. Separation of Lenalidomide was successfully achieved on a Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol: Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Lenalidomide. The correlation coefficient was found to be 0.9995 for Lenalidomide. The LOD and LOQ for Lenalidomide were found to be 5.004μg/mL and 15.164μg/mL respectively. The proposed method was found to be good percentage recovery for Lenalidomide, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

PAGES: 43-55  |  884 VIEWS  181 DOWNLOADS