"Analytical Method Development and Validation for the Estimation of Cabotegravir Using RP-HPLC in Pharmaceutical Dosage Forms"

Abstract

Cabotegravir (CAB), a long-acting integrase strand transfer inhibitor (INSTI), represents a major breakthrough in HIV-1 prevention and treatment, offering superior patient adherence through extended dosing intervals. This study presents the development and validation of a robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the accurate quantification of Cabotegravir in its pharmaceutical dosage form. Chromatographic separation was achieved on a Shim-pack XR-ODS C18 column (150 × 4.6 mm, 5 µm) using a mobile phase of acetonitrile and phosphate buffer (75:25 v/v, pH 3.6), with UV detection at 254 nm. This analytical method produced a sharp, well-resolved peak with a retention time of 2.9 minutes. The method was validated according to ICH Q2(R1) guidelines and demonstrated excellent specificity, linearity (r² = 0.9987 over 20–100 µg/mL), precision (intra-day %RSD = 0.50, inter-day %RSD = 1.25), and accuracy (98–102% recovery). The limits of detection (LOD) and quantification (LOQ) were found to be 11.12 μg/mL and 33.70 μg/mL, respectively. Robustness testing confirmed the method's resilience to minor changes in analytical conditions. This validated RP-HPLC method is precise, sensitive, and reliable, making it ideally suited for the routine quality control and stability assessment of Cabotegravir in pharmaceutical formulations.