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TITLE:

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND TENOFOVIR IN TABLET DOSAGE FORM

AUTHORS:

G. Kamal Yadav*, P Vivek Sagar, P

ABSTRACT:

A simple, Accurate, precise method was developed for the simultaneous estimation of the Lamivudine and Tenofovir in Tablet dosage form. Chromatogram was run through C18 Inertsil 5µ, 250mm×4.6mm column using phosphate buffer:acetonitrile:methanol(40:20:40) as mobile phase was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 257.0 nm. Retention time of Lamivudine and Tenofovir were found to be 3.4min and 4.5min. % RSD of the Lamivudine and Tenofovir were and found to be 0.42 and 0.21 respectively. The method is linear over a concentration range of 3.75 – 22.50 µg/ml for Lamivudine and 50 to 300 µg/ml for Tenofovir. The method was validated for system suitability, accuracy, precision, linearity and ruggedness. The system suitability parameters were within limit, hence it was concluded that the method was suitable to perform the assay. It was also used for determining lower concentration of drug in its solid dosage forms. Therefore it was concluded that the proposed method can be used for analysis of Lamivudine and Tenofovir Disoproxil Fumerate in Pharmaceutical dosage forms. Key words: Tenofovir, Lamivudine, stability indicating, RP- HPLC

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