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Development and validation of a versatile HPLC-DAD method for simultaneous determination of the antiviral drugs daclatasvir, ledipasvir, sofosbuvir and ribavirin in presence of seven potential impurities. Application to assay of dosage forms and dissolution studies

Mostafa M Baker, Sherif F Hammad, Tarek S Belal
Drug Development and Industrial Pharmacy 2019 April 1, : 1-9
30929537
This study describes a simple, sensitive, specific and generic HPLC-DAD method for simultaneous determination of four drugs prescribed for treatment of Hepatitis C Virus (HCV) infection. Investigated drugs include daclatasvir (DAC), ledipasvir (LED), sofosbuvir (SOF) and ribavirin (RIB). Successful separation was accomplished using Thermohypersil BDS-C8 column (4.6 × 250 mm, 5 µm) with gradient elution of the mobile phase consisted of mixed phosphate buffer pH 7.5 and methanol. Gradient elution started with 25% methanol, ramped up linearly to 80% in 15 min then kept constant till the end of the run. Flow rate was 1.5 mL/min. Peak areas were measured at 235, 260, 315, and 332 nm for RIB, SOF, DAC, and LED, respectively. Peaks of the analytes were perfectly resolved with retention times 2.0, 12.1, 14.7, and 17.2 min for RIB, SOF, DAC, and LED, respectively. The developed method was validated according to ICH guidelines with respect to system suitability, linearity, ranges, accuracy, precision, specificity, robustness, and limits of detection and quantification. The proposed method showed good linearity in the ranges 5-500, 2-300, 0.5-75, and 0.5-75 µg/mL for RIB, SOF, DAC, and LED respectively. Limits of detection were 0.10-0.66 μg/mL for the analyzed drugs. Specificity was established by separation of target drugs from 7 process-related impurities for SOF including its major metabolite (GS-331007). Applicability of the proposed method to real life situations was assessed through the analysis of four different pharmaceutical formulations and satisfactory results were obtained. Additionally, dissolution profiles of the 4 drugs were studied using the developed method.

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