A Novel Method Development & Validation Of Analytical Method For Containment Verification Of Lenalidomide Using HPLC UV Detector

The containment verification of pharmaceutical compounds is crucial to ensure product quality, safety, and compliance with regulatory standards. Lenalidomide, a potent drug used in the treatment of multiple myeloma and other hematological conditions, demands rigorous containment measures due to its potency and potential health hazards[1]. This abstract outlines the analytical method development and validation process for the containment verification of lenalidomide[2-5]. The method development phase involved the selection of appropriate analytical techniques capable of accurately quantifying lenalidomide at trace levels in various matrices, including air, surfaces, and personnel protective equipment (PPE)[6]. The method developed by using High-performance liquid chromatography (HPLC) coupled with UV-detector. The preferred method owing to its sensitivity, selectivity, and robustness. Validation of the developed method encompassed specificity, linearity, accuracy, precision, detection limit, quantification limit, and robustness studies. Specificity was confirmed by demonstrating the absence of interference from excipients, or environmental contaminants. Linearity was established over a wide concentration range, ensuring the method's suitability for quantifying lenalidomide at different levels. Linearity cover in the range of 0.02ppm to 10 ppm, having LOQ 0.02 ppm and LOD 0.01 ppm. In conclusion, the developed and validated analytical method offers a reliable approach for containment verification of lenalidomide in pharmaceutical manufacturing facilities. Implementation of this method facilitates compliance with regulatory requirements, ensures product quality, and safeguards the health and safety of personnel involved in handling potent compounds like lenalidomide[7]. This is unique method for determination of containment of lenalidomide using HPLC with UV detector.