Abstract
Recently approved anti-HCV drugs are a breakthrough new medication for the treatment of all genotypes hepatitis C virus infection. A selective, non-destructive and precise fourier transform infrared (FTIR) spectroscopic method was established and validated for the direct determination of daclatasvir dihydrochloride (DAC) and sofosbuvir (SOF) in pharmaceutical dosage forms. The method based on measurement the stretching bands of carbonyl group spectral range from 1695 to 1740 cm−1 for the studied drugs. The suggested procedures were completely validated through ICH guidelines with linear ranges of 0.25 −20.0 and 0.5 −20.0 mg g−1 for DAC and SOF, respectively. The values of LOQ were 0.149 and 0.172 and the values of LOD were 0.049 and 0.057 mg g−1 for DAC and SOF, respectively. Also, the analytical procedure was developed in agreement with green chemistry and the obtained results are found to be in a good agreement with that of the destructive methods. Moreover, the method was successfully applied for the direct and rapid supervision the uniformity of dosage units for the studied anti-HCV drugs in their pharmaceutical tablets dosage form.
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