ISSN: 2249-9504
CAS CODEN: IJPCDX

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Citations : 3566

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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORMS

Abstract

Author(s): Anil Yadav Nodagala1*, K.Mangamma2, G.Mani Kumar3and D.Venkata Rao4

The mechanism of the RP-HPLC is the retention, by the interaction of non-polar hydrocarbon chain of stationary phase with non-polar parts of the sample molecules.This method had been developed for simultaneous determination of antiretroviral drugs which are widely used such as, Abacavir Sulphate and Lamivudine in Tablet dosage form and was carried on column Inertsil ODS (150×4.6, 5μm)with UV detection at 254 nm using a mobile phase composition of mixed phosphate buffer (pH 4.0) and Acetonitrile at a flow rate of 1ml/min. The proposed method was validated in terms of linearity, accuracy, precision, robustness, ruggedness, specificity, limit of detection and limit of quantificationas per ICH and USP guidelines and it was found suitable for the routine quality control analysis of the drugs in tablet dosage forms.Linearity of abacavir and lamivudine were found in the range of 20-120μg/ml and 10-60 μg/ml respectively.The limit of detection was found to be 0.0049 and 0.0268 for abacavir and lamivudine respectively. Limit of quantification was found to be 0.0184 μg/ml and 0.0150 μg/ml for abacavir and lamivudine respectively.Hence, it was concluded, chromatographic method developed for abacavir sulphate and lamivudine said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutics and bio-equivalence studies and in clinical pharmacokinetic studies.

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