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Asian Journal of Pharmaceutical Analysis
Year : 2016, Volume : 6, Issue : 2
First page : ( 115) Last page : ( 118)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2016.00017.X

Stability Indicating HPLC Method Development and Validation for Thalidomide and its Impurity Determination

Chandana O.S.S.1, Babu R. Ravichandra1,*

1Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, India

*Corresponding Author E-mail: rrcbabu7@yahoo.in

Online published on 21 July, 2016.

Abstract

A simple, accurate, precise, stability indicating HPLC method was carried for the determination of thalidomide along with its impurities. An HPLC isocratic separation was achieved on Develosil ODS UG-5 column (150mm X 4.6 mm X 5um particle size) with a mobile phase 0.01M potassium dihydrogen orthophosphate and Acetonitrile in the ratio of 80:20 (v/v) 1.02gm in 500 ml. The flow rate was set at 0.700ml with a detection wavelength of 297nm. The linearity range of thalidomide and its impurities were 0.99914, 0.99966 and 0.99968 respectively. The drug undergoes degradation under acid, base, H2O2, thermal and humidity conditions. The method was validated for precision, accuracy, ruggedness and robustness as per ICH guidelines.

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Keywords

Thalidomide, HPLC, Stability indicating, Method validation.

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