RP-HPLC method development and validation for the simultaneous determination of lamivudine, abacavir and dolutegravir in pharmaceutical dosage forms

Abstract

Abacavir is an antiretroviral drug used to treat HIV/AIDS. Lamivudine (2′,3′-dideoxy-3′-thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI). Dolutegravir (DTG) is an FDA-approved drug for the treatment of HIV infection. Dolutegravir is an integrase inhibitor. A combination product of the above three drugs is being marketed under the brand name of Triumeq in India. In the present study focus is laid on this triple combination drug, The retention times of Lamivudine, Abacavir and Dolutegravir were found to be 2.2 min, 2.9 min & 7.4 min respectively. Regression coefficient r² value was 0.999 for Lamivudine, Abacavir and Dolutegravir and the response was linear. The percentage mean recovery of Lamivudine, Abacavir and Dolutegravir were found to be 100.04, 99.73 and 100.29% respectively. %RSD values of repeatability and intermediate precision were ≤2 and the method is precise. The solution stability studies of method indicate that the Lamivudine, Abacavir and Dolutegravir drugs were stable up to 24 hours. Hence, the developed method can be successfully employed for routine quality control of Lamivudine, Abacavir and Dolutegravir in drug testing laboratories and pharmaceutical industries.