A new rapid HPLC method for the analysis of lenalidomide related substances in bulk drug samples

Abstract

Lenalidomide is a dicarboximide that consists  of 1-oxoisoindoline  bearing  an  amino  substituent  at position 4  and  a 2, 6- dioxopiperidin-3-yl group at position 2. It inhibits the secretion of TNF-alpha. It has a role as an angiogenesis inhibitor, an antineoplastic agent, and an immuno modulator. It is a member of isoindoles, a dicarboximide, a member of piperidones, and an aromatic amine. A new chromatographic method was established for the determination of lenalidomide and related substances using Phenomenix C18 (250 × 4.6 mm, 5 µm) HPCL column with gradient method at ambient temperature. The chromatographic separation was clear at a flow rate of 0.8 ml/min is maintained and all degradation studies are performed at 210 nm. Method Validation is carried out according to International Council for Harmonization (ICH) guidelines and the parameters namely; precision, accuracy, specificity, stability, robustness, linearity, the limit of quantitation (LOQ), and limit of detection (LOD) are evaluated. The present developed RP-HPLC method shows the purity angle of peaks is less than their threshold angle, signifying that it to be suitable for stability studies. Hence, the developed method can be used for the successful separation of LLM and its impurities in the pharmaceutical dosage formulations.