Multivariate optimization and evaluation of quaternary mixture in bulk and co-formulated dosage forms by central composite design

Abstract Background The current study describes the use of central composite design for multivariate optimization resolution and retention time, taking into account different critical method parameters like organic phase, pH, flow rate, wavelength risk assessment. chromatographic assay most effective anti-viral regimen (EPCLUSA, DARVONI, HARVONI) was developed. An experimental presented by sequential investigation four independent parameters. developed using XTERRA C18 (250 mm × 4.6 mm, 5 μm particle size) column in isocratic mode potassium dihydrogen phosphate buffer (pH adjusted to 5) acetonitrile (50:50 % v/v) as mobile phase at a rate 1.0 ml/min UV detection 260 nm. Results separation drugs with fine preferable times achieved. Retention were found be 2.96, 3.91, 7.15, 11.94 min daclatasvir, sofosbuvir, velpatasvir, ledipasvir, respectively. percentage accuracy labelled claim range 99–102%, pooled %RSD repeatability, precision, less than 2% . Conclusion suggested applied quantification identification studied tablets; results agreed label validated according ICH guidelines. optimized can used pharmacokinetic quality control studies.