Abstract

A NOVEL QUANTITATIVE ESTIMATION OF DACLATASVIR AND SOFOSBUVIR IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Gollapalli Nagaraju*, Ritesh Agrawal and Rama Rao Nadendla

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Abstract

Objective: A Simple, accurate, specific and rugged reverse phase liquid chromatographic method was developed and validated for the simultaneous estimation of Daclatasvir and Sofosbuvirin bulk and tablet dosage form. Method: A reverse phase gradient program has been developed to separate the all four active ingredients using a mixture of Acetonitrile: Methanol: 0.1% Triethylamine buffer(pH-3.0) 25:35:40 (v/v/v) as mobile phase. Aisocratic elution has been developed and validated, on a reverse phase Inertsil ODS-C18 column (250 x 4.6mm,5μ)with a flow rate of 1 mL/min by monitoring at 250 nm of wavelength. Results: The mean retention times of Daclatasvir and Sofosbuvirwere found to be 2.09 and 3.50 min respectively. Linearity of Daclatasvir and Sofosbuvirwas found to be 5-25μg/mL and 2-10μg/mL respectively. The accuracy of the proposed method was determined by performing recovery studies and was found to be between 98-102%. The repeatability testing for both sample and standard solutions was found as % RSD

Keywords: Sofosbuvir, Daclatasvir; RP- HPLC; Validation, Chromatography.