CHEMOMETRICS ASSISTED SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND DACLATASVIR DIHYDROCHLORIDE IN TABLET FORMULATION

Four chemometric methods, namely Classical Least Square (CLS), Inverse Least Square (ILS), Partial Least Square (PLS) and Principal Component Regression (PCR), were developed for the simultaneous estimation of sofosbuvir and daclatasvir dihydrochloride in tablet formulation. Full factorial design was used to construct calibration set as well as validation set. Twenty five mixed solutions were prepared for calibration set and sixteen mixed solution of drugs were prepared for validation set. The absorbance of all prepared solutions was measured in the range of 230 nm to 335 nm at 16 wavelength points at an interval of 7 nm. Linearity was observed in the range of 10 – 90 µg/mL for sofosbuvir and 4 - 20 µg/mL for daclatasvir dihydrochloride. The developed chemometric methods were validated in terms of precision and accuracy as per ICH guidelines. The developed methods can be applied for the routine quantitative analysis of formulation.