| Popis: |
A novel, simple, accurate and rapid method has been developed and validated for the estimation of Elbasvir and Grazoprevir in bulk and in tablet dosage form. In RP-UPLC method, elution was achieved in isocratic mode using combination of 0.1% Formic acid in water and Acetonitrile in the ratio of 50:50 v/v using an Acquity UPLC BEH C18, 75 x 2.1 mm, 1.7 mm column. The flow rate was 0.3mL/min and detection was done at 264 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity. The peak retention times obtained for elbasvir and grazoprevir were 0.6 and 1.2 min respectively. The linearity range for elbasvir was found to be 5 to 30 µg/mL and for grazoprevir was 10 to 60 µg/mL, respectively. The forced degradation studies were also conducted on drug substances as per ICH norms and found that the developed method was stability indicating. Keywords: Elbasvir, Grazoprevir, RP-UPLC, Validation. |
