Application of Reversed-Phase HPLC Method for the Simultaneous Determination of Lenacapavir and Bictegravir in Tablets Dosage Form

Background: Human Immunodeficiency Virus is a debilitating viral infection that compromises the immune system, rendering individuals vulnerable to opportunistic infections. While antiretroviral therapy can effectively manage the condition, the development of novel treatment strategies remains crucial. This study aims to create and validate a robust reversed-phase HPLC routine for the concurrent quantification of lenacapavir and bictegravir, two antiretroviral agents. Materials and Methods: A novel chromatographic separation method was developed utilizing a Hypersil ODS C-18 column (4.6x250 mm, 5 mu m particle size). The mobile phase, a gradient mixture of 0.1% OPA buffer and acetonitrile, was optimized for efficient analyte elution. Chromatographic detection was performed at 220 nm with a flow rate of 1.0 mL per minute, injecting 20 mu L of sample volume for each analysis. Results: Linearity for lenacapavir was established across a concentration range of 72-216 mu g/mL, while bictegravir demonstrated linearity from 24-72 mu g/mL. The chromatographic retention times for lenacapavir and bictegravir were computed to be 2.17 and 11.46 min, respectively. Recovery studies indicated that both analytes could be accurately quantified, with recovery percentages falling within the 98-102% range. Conclusion: In accordance with ICH requirements, the novel approach was successfully validated. The devised method is dependable and cost-effective for routine analysis with respect to all parameters that have been evaluated.