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ISSN 2063-5346
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Development of Method Validation for Related Substances In lenalidomide Capsules with HPLC Method

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Smita Kothakummari1, D. Gavaskar*, V D N Kumar Abbaraju2*Anil Kumar. K3, Bavireddy Mohan4
» doi: 10.48047/ecb/2023.12.10.776

Abstract

A validated HPLC method was developed for the determination of Lenalidomide(LLE) in pharmaceutical formulation. Isocratic elution at a flow rate of 1.0ml/min was employed on Zorbax SB C8 3.5μm × 4.6 mm, 150mm, or similar is used for this chromatography analysis and the column temperature is maintained as ambient.The Mobile phase is a mixture of pH 6.1buffer and Methanol in the ratio of 95:5%v/v as mobile phase-A and the mixture of pH 6.1buffer and Methanol in the ratio of 5:95%v/v as mobile phase-B was used. Flow rate was identified at 1.0ml/min. a 5.0μl sample was injected. The run time is 52 minutes to Sample, blank, system suitability, furthermore 55 minutes to diluted standard. Retention time is noted for LLE is 18.1 minutes. The% R.S.D to LLE is measured. Mean percentage recovery to LLE is identified and it is found that within specification limit. The proposed HPLC processshould successfully applied to routine quality control analysis of formulations. The method developed in this article is more simple and is much better than the methods reported in the literature.

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