A Review on Method Development and Validation of Selected Anti Viral Drug Lenacapavir by Using Different Analytical Techniques

Lenacapavir is a long-acting, first-in-class HIV-1 capsid inhibitor used for the prevention and treatment of HIV-1 infection. It acts by binding to the HIV-1 capsid protein and interfering with multiple stages of the viral replication cycle. Lenacapavir disrupts capsid assembly and disassembly, thereby affecting the proper formation and maturation of viral particles. Analytical method development is essential for the accurate identification, estimation, purity determination, and quality control of lenacapavir in pharmaceutical formulations. Various analytical techniques, including UV-visible spectroscopy, HPLC, RP-HPLC, HPTLC, and LC-MS, can be employed for the estimation of lenacapavir. Method validation ensures that the developed analytical procedures provide reliable, accurate, precise, and reproducible results. Important validation parameters include accuracy, precision, specificity, linearity, range, robustness, limit of detection, and limit of quantification. This review focuses on different analytical methods reported for the determination of lenacapavir and evaluates their analytical performance. It also highlights the applicability of different techniques for routine pharmaceutical analysis and quality control of lenacapavir.