Method development and validation for simultaneous estimation of lamivudine, dolutegravir and tenofovir disoproxil fumarate in bulk and pharmaceutical dosage form using RP-HPLC and its application to in-vitro dissolution study

Y. Haribabu, K. Nihila*, VK. Sheeja, MB. Akhil

Grace College of Pharmacy, Kodunthirapully, Palakkad, Kerala, India

ABSTRACT

A simple, rapid, and economical method has been developed for the simultaneous estimation of the latest FDA approved antiviral drug combination, Dolutegravir, Lamivudine, and tenofovir disoproxil fumarate in tablet dosage form using Shimadzu LC-20 AT HPLC with a Phenomenex Luna column compartment., the method was developed using HPLC graded methanol with o-phosphoric acid as a mobile phase and successfully validated the developed method as per the ICH guidelines. The method was found to be linear, accurate, precise, robust, and rugged. The limit of detection and the limit of quantification was found to be 2.6μg/ml and 8.18μg/ml for Dolutegravir, 14.63 μg/ml and 44.35 μg/ml for Lamivudine and 16.43 μg/ml and 49.81 μg/ml for tenofovir disoproxil fumarate respectively. The retention time was found to be 3.0, 2.3 and 2.7 min for Dolutegravir, Lamivudine and tenofovir disoproxil fumarate respectively. All of assessed parameters complied with the acceptance criteria hence indicated the usefulness of the RP-HPLC method for the determination of assay and in-vitro dissolution study for tablet dosage form which contains lamivudine, tenofovir disoproxil fumarate, and dolutegravir active substances. Hence the method can be applied for routine quality control of the drugs.

Keywords:

Dolutegravir, Lamivudine, Tenofovir disoproxil fumarate, RP-HPLC, in-vitro dissolution study, Antiretroviral