Abstract

A REVIEW ON DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISPROXIL AND DOLUTEGRAVIR IN BULK AND COMBINED DOSAGE

Nachiket Dighe, Prachi P. Kanawade* and Ganesh S. Shinde

Abstract

Lamivudine is an antiretroviral medication used to prevent and treat HIV or AIDS. It is also used in the treatment of hepatitis B when other options are not possible. The drug lamivudine was patented in 1995 and was approved for use in the U.S. in 1995. It shows its action by blocking the enzyme HIV reverse transcriptase. Lamivudine comes under the category of nucleoside reverse transcriptase inhibitor. Tenofovir disproxil is an agent which can be used with other antiretroviral agents, shows its action as a nucleotide reverse transcriptase inhibitor and lowers the ability of the virus to replicate. It is used when there is high risk before exposure for treatment of HIV or AIDS. Dolutegravir is an antiretroviral agent which is also used for prevention and in the treatment of HIV or AIDS. It is a HIV integrase strand transfer inhibitor. It works by blocking the functions of HIV integrase which is important for replication of virus. Dolutegravir and Abacavir and Lamivudine combination is widely used to treat HIV. The objective of this review is, to describe and develop simple, accurate and selective method for estimation of Lamivudine, Tenofovir Disproxil and Dolutegravir in the bulk and tablet dosage form by RP-HPLC technique. The RP-HPLC technique can be validated by various parameters like system suitability, method precision, accuracy, linearity, limit of detection and limit of quantitation, robustness, etc.

Keywords: Lamivudine, TenofovirDisproxil, Dolutegravir, HIV, Hepatitis B, RP-HPLC.