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  • Chem Sci Trans., 2020, 9(1),  pp 10-22  

    DOI:10.7598/cst2020.1706

    Research Article

    Method Development, Validation and Forced Degradation Studies of Dolutegravir, Anti-Retroviral Drug Using Reverse Phase-High Performance Liquid Chromatography

  • E. DIVYA* and K. BHAVYASRI
  • RBVRR Women?s College of Pharmacy, Hyderabad, India
  • Abstract

    A simple, precise, accurate method was developed for the estimation of dolutegravir by RP-HPLC technique. Chromatographic conditions used are stationary phase Ascentis C18 150 mm x 4.6 mm, 2.7 μ, Mobile phase 0.01N KH2PO4 Buffer: Acetonitrile in the ratio of 60:40. Then pH adjusted to 3.5 with orthophosphoric acid. And flow rate was maintained at 1 mL/min, detection wavelength was 257 nm, column temperature was set to 30 oC and diluent was mobile phase conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25 to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.3 for repeatability and 0.8 for intermediate precision. LOD and LOQ are 0.08 μg/mL and 0.24 μg/mL respectively. By using above method assay of marketed formulation was carried out 99.66% was present. Degradation studies of dolutegravir were done, in all conditions purity threshold was more than purity angle and within the acceptable range.

    Keywords

    RP- HPLC, Dolutegravir, Method development, Validation, ICH Guidelines

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