Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2013 Vol: 5 Issue: 8

Development and validation of HPTLC method for estimation of efavirenz in human plasma

Abstract

Efavirenz is an anti-HIV drug. A simple, selective, and sensitive high performance thin layer liquid chromatographic (HPTLC) method for the determination of Efavirenz in human plasma has been developed. The method utilizes Liquid liquid extraction as the sample preparation technique using methanol for final reconstitution of the samples. The HPTLC separation was achieved on the aluminum backed layer of silica gel 60F254 using (Dichloromethane: Methanol) (5:0.3 v/v) as mobile phase. Quantification was achieved with HPTLC detection at 247 nm over the concentration range of 200 to 1400 ng/band(2μg/ml to 14μg/ml) with recovery in the range of 96.59- 96.69% for Efavirenz. Retention factor (Rf) for EFV and the internal standard were 0.69 and 0.34 respectively. The method is simple and extended for routine analysis in human plasma and can further be extended to pharmacokinetic studies. Efavirenz in plasma samples was stable when tested as per US CDER guidelines. The method showed acceptable values for accuracy, precision, recovery, sensitivity and stability.