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Method development and Validation towards simultaneous estimation of Lamivudine and Dolutegravir in the bulk and tablet dosage forms under the influence of stress degradation conditions by using RP-HPLC method.

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» doi: 10.48047/ecb/2023.12.12.83


For the precise, simultaneous estimation of combined dolutegravir & lamivudine drugs in the tablet as well as bulk dosage forms, a simple accurate, and exact approach has been established. An Inertsil ODS (4.6 x 250mm, 5 μm) portable stage with an 80% buffer and 100% acetonitrile was used to run the chromatogram. The flow rate of 1 ml per min and the temperature was being maintained at 30 degree Celsius with improved wavelength was fixed at 260 nm. The retention time (RT) for Lamivudine & Dolutegravir were observed at 3.60 and 5.14 minutes, respectively. The percentage purity of Lamivudine and dolutegravir was detected to be 99.97% and 100.64%, respectively. The theoretical plates and tailing factor for Lamivudine and Dolutegravir were found to be 3381.91, 4959.43, 1.14, and 1.13, respectively, as system suitability characteristics. The percentage mean recovery was 99.64% and 100.01%, respectively, for Lamivudine and Dolutegravir, RSD was 0.4% and 0.8% towards repeatability, and 0.1 & 0.7 for the intermediate precision, respectively. %RSD for repeatability remained at 0.4 and 0.8 percent. The precision of the academic work remained exact, strong, and repeatable. The results for LOD and LOQ were 3.00 and 3.02, and 9.98 and 10.00. The results of the study revealed that the recommended Reverse Phase HPLC technique is exact, simple, powerful, quick, and reproducible. This could be used to regularly assess themass and tablet measurements of lamivudine and dolutegravir.Dolutegravir, Lamivudine, RP-HPLC, and simultaneous estimation

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