Abstract
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR AND LAMIVUDINE IN DRUG PRODUCT

*Dr. P. T. S. R. K. Prasada Rao

ABSTRACT

The aim of the method was to develop and validate a rapid, sensitive and accurate method for simultaneous estimation of Lamivudine and Dolutegravir in drug product by liquid chromatography. The chromatographic separation was achieved on the C18 column (Inertsil ODS 3V 250*4.6, 5um) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoroacetic acid in water: Acetonitrile (35:65). The flow rate was 0.8ml/ minute and ultraviolet detector at 260nm. The average retention time for Lamivudine and Dolutegravir found to be 2.984 min and 4.340 min. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 300.0 – 900.0μg/mL for Lamivudine and 50.0 - 150.0μg/mL of Dolutegravir.

Keywords: Lamivudine, Dolutegravir, Isocratic, HPLC, Phenyl, Trifluoroacetic acid, Acetonitrile, Methanol, and validation.


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