A Novel UPLC-PDA Stability Indicating Method Development and Validation for the Simultaneous ...

The aim is to establish a stability-indicating Rp-UPLC method for determining Lamivudine, Dolutegravir, and their degradants in tablets simultaneously. The chromatographic separation was carried out on a BEH Shield RP18 (2.1 mmX100 mmX1.7 mm) column with an isocratic mobile phase of potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid: methanol (30:70, percent v/v) at a flow rate of 0.5 ml/min. The column was held at room temperature, and the eluents were measured at 258 nm. The retention times of the analytes were found to be 0.81 and 2.78 minutes, respectively, for Lamivudine and Dolutegravir. The regression coefficient (r2) for the calibration of peak area versus concentration, which was linear from 105 to 315 g/ml for Lamivudine and 17.5 to 52.5 g/ml for Dolutegravir, was greater than 0.999. For simultaneous determination of Lamivudine and Dolutegravir in tablets, the method had the necessary accuracy, precision, and robustness.Conclusion: The proposed method for the simultaneous analysis of Lamivudine and Dolutegravir in pharmaceutical formulations is convenient, inexpensive, reliable, and precise, and it can be effectively used in routine quality control.

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