Khalid A M Attia, Nasr M. El-Abasawi, A. El-Olemy
Jan 2, 2017
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Influential Citations
14
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Journal
Analytical Chemistry Letters
Abstract
Abstract Simeprevir is a novel direct acting antiviral agent against hepatitis C virus. In the present work, a rapid, specific and reproducible reversed phase high performance liquid chromatography with diode array detection (HPLC-DAD) method has been developed and validated for the determination of simeprevir in the presence of its forced degradation products. The drug was subjected to variable stress conditions including hydrolysis, oxidation, thermal and photolysis. The drug was found to be labile to acidic hydrolysis, basic hydrolysis, oxidation and photolysis but stable in thermal and neutral hydrolytic conditions. Successful chromatographic separation of simeprevir was achieved on Discovery® HS C18 column at a flow rate of 1 mL/ min using mobile phase of acetonitrile. The eluents were monitored by the diode array detector and peak area values were measured at 288 nm. The validity of the method was assessed by evaluating accuracy, precision, specificity and robustness. The linear regression analysis data for the calibration curve shows a good relationship in the range of 1.5 - 45 μg/mL. The developed method was successfully applied for the estimation of simeprevir in its commercial dosage form and could be used for the routine analysis of the studied drug in quality control laboratories.