Simultaneous UV-spectrophotometric determination of tertiary components in FDC of lamivudine, tenofovir disoproxil fumarate, and efavirenz in solid dose formulation

Abstract

Developing a single spectroscopic analytical approach for estimating individual medications in formulations with multiple components is a difficult task. A simultaneous UV-spectrophotometric approach was used to analyze the antiretroviral (ARV) medications including Lamivudine (3TC), Tenofovir disoproxil fumarate (TDF), and Efavirenz (EFV) in a fixed drug combination (FDC). TDF, EFV, and 3TC had maximum absorptions at 230, 247, and 270 nm in 0.1 HCl, respectively. Method validation demonstrated repeatability and robustness, with linearity ranging from 2-10 ug mL-1 for 3TC, 1-5 ug mL-1 for TDF, and 10-50 ug mL-1 for EFV, respectively, with correlation coefficients (r) of 0.999, 0.998, and 0.998. The percentage drug contents for 3TC, TDF, and EFV were 98.44±1.26%, 97.52±0.72%, and 99.43±1.44%, respectively. The approach was free of excipient interference and could be utilized to detect multicomponent ARVs in FDCs.