DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND DOLUTEGRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS

The present study was undertaken to develop and validate a simple, rapid, precise, accurate, robust, and stability-indicating Ultra Performance Liquid Chromatographic (UPLC) method for the simultaneous estimation of Lamivudine and Dolutegravir in bulk drugs and pharmaceutical dosage forms. Chromatographic separation was achieved using a Hibar C18 column (100 × 2.1 mm, 2 µm) with an isocratic mobile phase comprising 0.01 N potassium dihydrogen phosphate buffer and acetonitrile (60: 40, v/v) at a flow rate of 0.30 mL/min. Detection was performed at 257 nm using a PDA detector, and the total run time was 3.0 minutes. The developed method was validated according to ICH Q2(R2) guidelines for system suitability, specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), limit of quantification (LOQ), and forced degradation studies. The method exhibited excellent linearity with correlation coefficients greater than 0.999 for both drugs. Recovery values ranged from 99–100%, while precision studies showed %RSD values below 2.0%. The proposed method effectively separated the analytes from their degradation products under various stress conditions, confirming its stability-indicating nature. Assay results of the marketed formulation complied with pharmacopeial specifications. The validated UPLC method was found to be reliable, reproducible, sensitive, and suitable for routine quality control, stability testing, and pharmaceutical analysis of Lamivudine and Dolutegravir in combined dosage forms.