Abstract

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Title DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE DETERMINATION OF DACLATASVIR DIHYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Authors Milon Mondal
Description

A simple, rapid reverse phase high-performance liquid chromatographic method has been developed and validated for the estimation of Daclatasvir Di-hydrochloride (DTDH) in bulk and in a pharmaceutical dosage form. Chromatography was carried out by Spherical Octyl Silane (C8 silica, column 250 x 4.6mm internal diameter was 5-μm), using mobile phase of composition of tri-ethylamine buffer (pH 5.00): acetonitrile (50:50 (v/v)). The flow rate was 1.0 mL min-1 and a peak was observed at about 6.13 minute as detected by a UV detector at 315 nm. The method was validated according to ICH guideline, checking the different analytical parameters such as linearity, precision, accuracy, specificity and robustness. The calibration curve was found to be linear (r2 =0.9997) for the analyte DTDH in the concentration range of 15-45μg/mL. The average recovery was found to be 98.42% to 100.64% for DTDH.

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