ABSTRACT

A simple, precise, accurate, efficient and reproducible, isocratic Reverse Phase- High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Lamivudine and Dolutegravir in bulk and tablet dosage form. Lamivudine and Dolutegravir were separated using a Shimadzu column the mobile phase contained a mixture of Methanol and 0.1% TFA (TriFluoro Acetic acid),(65:35 v/v). The flow rate was set to 1.0 ml/min. with the response measured at 266nm. The retention time of Lamivudine and Dolutegravir was found to be 2.769 min. and 7.496 min. respectively with a resolution of 11.429. Linearity was established for Lamivudine and Dolutegravir in the range of 12-60µg/ml.and 03-10µg/ml. with correlation coefficient of 0.9997 and 0.9993. The percentage recovery of Lamivudine and Dolutegravir was found to be 99.97%, and 99.93% respectively. Validation parameters such as specificity, linearity, precision, accuracy, robustness, limit of detection(LOD), limit of quantification (LOQ) was evaluated for the method according to the International Conference on Harmonization (ICH) Q2 (R1) guidelines. Keywords: Lamivudine, Dolutegravir, RP-HPLC, Methanol, Trifluoro acetic acid
Publication date: 01/02/2022

https://ijbpas.com/pdf/2022/February/MS_IJBPAS_2022_5909.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.2.5909