DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND DOLUTEGRAVIR SODIUM IN TABLET DOSAGE FORM

Abstract

ABSTRACTA simple, specific, precise, and accurate RP-HPLC method was successfully developed forthe simultaneous estimation of Lamivudine and Dolutegravir sodium in tablet dosage forms.Spectral scanning was carried out using a JASCO UV spectrophotometer with quartz cuvettesfor sample analysis. The overlain spectra of Lamivudine and Dolutegravir showed a commondetection wavelength at 269 nm. Chromatographic separation was achieved using an AgilentPoroshell C18 column (150 mm × 4.6 mm, 5 µm) with a mobile phase consisting ofMethanol and 0.1% OPA in water in the ratio of 50:50. The flow rate was maintained at 1.0mL/min. The retention times for Lamivudine and Dolutegravir sodium were found to beapproximately 10 minutes. The method exhibited good linearity within the concentrationrange of 6–90 µg/mL for both drugs. The percentage recovery of Lamivudine andDolutegravir sodium was found to be 99.41%, indicating the accuracy of the method. TheLimit of Detection (LOD) and Limit of Quantification (LOQ) for Lamivudine were observedto be 2.549 µg/mL and 7.723 µg/mL, respectively, whereas for Dolutegravir they were 0.219 µg/mL and 0.664 µg/mL, respectively. The developed method was validated according toICH guidelines for various analytical parameters such as linearity, precision, accuracy, LOD,LOQ, selectivity, robustness, and ruggedness. The validated method was successfully appliedfor the simultaneous estimation of Lamivudine and Dolutegravir sodium in tablet dosageforms.