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E-Journal of Chemistry
Volume 9 (2012), Issue 3, Pages 1165-1174

Development of a Rapid and Sensitive HPLC Assay Method for Lenalidomide Capsules and Its Related Substances

1Department of Chemistry, Sri Krishnadevaraya University, Sri Venkateswara Puram, Anantapur-515 055, Andhra Pradesh, India
2Department of Nanomaterial Chemistry, Donguguk University, 707 Seokjang-Dong, Gyeongju-780 714, Republic of Korea
3Department of Chemistry (GEBH), Sreevidyanikethan Engineering College (Atonomous), Sri Sainath Nagar-517 501 A.Rangampet, Tirupathi, Andhrapradesh, India

Received 23 July 2011; Accepted 5 September 2011

Copyright © 2012 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


A chromatographic method was established for the determination of lenalidomide and related substances in 10 mg and 5 mg capsules using Sunfire C-18(250×4.6 mm ID, 5 μm) HPCL column with 85:15 v/v ratio of mobile phases A (mixture of phosphoric acid buffer and 1-octane sulphonic acid sodium salt) and B(55: 45 v/v ratio of methanol and acetonitrile) at 40°C and 210 nm wave length. The degradation studies were performed using 0.1N HCl, 0.1 N NaOH, 1% v/v hydrogen peroxide, humidity, UV at 254 nm, Sun light, and heat to 60°C. No significant degradation of lenalidomide was observed. However, the slight degradation was observed in presence of NaOH. The developed HPLC method gave the peaks purity angle was less their threshold angle, indicating it to be suitable for stability studies. It was validated with respect to linearity, accuracy, precision, ruggedness, and robustness.