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  • Chem Sci Trans., 2019, 8(4),  pp 477-486  

    DOI:10.7598/cst2019.1700

    Research Article

    Validated Stability Indicating HPLC Method for Estimation of Daclatasvir

  • K. V. LALITHA1*, J. RAVEENDRA REDDY1 and N. DEVANNA2
  • 1Division of Pharmaceutical Analysis and Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous Ananthapuramu-515172, Andhra Pradesh, India
    2Jawaharlal Nehru Technological University- OTPRI, Ananthapuramu, Andhra Pradesh, India
  • Abstract

    For the determination of daclatasvir from formulation, a new, simple, specific, accurate and robust isocratic reversed-phase (RP) stability indicating high-performance liquid chromatographic (HPLC) method has been developed and validated. The liquid chromatographic separation isocratically accomplished by means of a portable acetonitrile, buffer (0.1% Octa sulphonic acid) (70:30). The analysis was carried out using at ambient temperature on Xterra C18 (4.6x150 mm, 5.0 μm) at flow rate of 1 mL/min and the UV detection at 237 nm. The method was validated for accuracy, precision, linearity, range, selectivity and robustness. The linearity of the proposed method was investigated in the range of 20 to 100 μg/mL (r2 = 0.999). The drug was subjected to oxidation, hydrolysis, heat and photolysis to apply stress conditions. The method provided good peak parameters with retention time of 2.398 min. Degradation products resulting from stress studies did not interfere with the detection of daclatasvir and the assay can thus be considered as stability-indicating HPLC method.

    Keywords

    Assay, High performance liquid chromatography, Reverse phase, Daclatasvir validation

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