Reversed-Phase Liquid Chromatographic Method for Determination of Daclatasvir Dihydrochloride and Study of Its Degradation Behavior |
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Authors: | Sonia T. Hassib Elham A. Taha Ehab F. Elkady Ghada H. Barakat |
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Affiliation: | 1.Pharmaceutical Chemistry Department, Faculty of Pharmacy,Cairo University,Cairo,Egypt;2.National Organization for Drug Control and Research (NODCAR),Giza,Egypt |
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Abstract: | A simple and selective reversed-phase stability-indicating liquid chromatographic method has been developed and validated for the determination of daclatasvir in drug substance and drug product. Daclatasvir was subjected to acidic, alkaline, oxidative, thermal and photo-degradation study. The LC method was based on isocratic elution of daclatasvir and its degradation products on a reversed-phase C18 Hypersil column using a mobile phase consisting of phosphate buffer (10 mM, 1 mL triethylamine L?1): acetonitrile (60:40 v/v) at a flow rate of 2 mL min?1. Quantitation was achieved with UV detection at 312 nm. Linearity, accuracy, and precision were found to be acceptable over the concentration range of 0.75–120 μg mL?1, with regression coefficient value of 0.9999, and with limit of detection and quantitation of 0.148 and 0.447 μg mL?1, respectively. Peak purity was checked for principle drug and its alkali induced degradation product, and the pathway of alkaline hydrolysis of daclatasvir was suggested by LC/MS. |
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