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Abstract
A simple stability indicating method was developed for the assay of daclatasvir dihydrochloride using the principles of high performance liquid chromatography. The drug was subjected to forced degradation. The drug was found to degrade in hydrolytic (acid, base and neutral) and oxidative conditions resulting in the formation of four degradation products (DP1 to DP4). The degradation products were well separated by using stationary phase of a Waters Symmetry C18 (150 x 4.6 mm, 5 μm) column with mobile phase consisting of 10 mM ammonium acetate (pH 5.0) and acetonitrile in gradient elution. Subsequently the degradation products were identified by an online LC-ESI-QTOF-MS/MS. The chemical structures were proposed with the support of mass fragmentation and accurate mass data. The developed analytical method was validated as per ICH Q2 (R1) guidelines. The proposed analytical method is very useful for the determination of daclatasvir and its degradation products in bulk drug or formulations thereby demonstrating its stability indicating potential.