Development of a reversed-phase HPLC method for determination of related impurities of Lenalidomide

In this project, we have developed a reversed phase liquid chromatography method for separation and determination of lenalidomide (LENA) and related substances by using C-8 (250×4.6 mm ID, 5 μm) HPCL column. The mobile phases A and B were phosphate buffer at Ph=3.30, and (methanol:acetonitrile)(1:5...

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Bibliographic Details
Published in:	Chemical review and letters Vol. 3; no. 2; pp. 61 - 64
Main Authors:	Seyyed Amir Siadati, Meghdad Payab, Abolghasem Beheshti
Format:	Journal Article
Language:	English
Published:	Iranian Chemical Science and Technologies Association 01-04-2020
Subjects:	hplc lenalidomide method development related substances uv detector
Online Access:	Get full text
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Summary:	In this project, we have developed a reversed phase liquid chromatography method for separation and determination of lenalidomide (LENA) and related substances by using C-8 (250×4.6 mm ID, 5 μm) HPCL column. The mobile phases A and B were phosphate buffer at Ph=3.30, and (methanol:acetonitrile)(1:5 V/V), respectively. The column oven temperature was 25°C, the wavelength was 220nm, and the injection volume was 20 µl. The degradation studies using basic, acidic, oxidation, and thermal stress, were performed. In addition, in the basic stress, a significant degradation for LENA, was observed.Also, the results showed that the resolutions of the peaks for fresh, acid stress, and thermal stress were considerably high. For example, in the case of thermal shock, the resolution of each peak to the next, was 3.6, 3.2, 5.3, and 4.7. Thus, it indicates that the method is suitable at least in view of separation and resolution for the peaks produced by thermal shock.
ISSN:	2676-7279 2645-4947