Improvement of Development and Validation of an RP-HPLC Method for The Fluvastatin Sodium Using QbD Approach and Its Application to Forced Degradation Studies

Abstract

The current examination portrays the improvement of the QbD way to deal with Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) framework utilizing Design of Experiments. Each of the three principle parts of the RP-HPLC measure (Buffer pH, Organic Step-percent acetonitrile, Organic Modifier-Methanol) are introduced in a successful test configuration zeroed in on methodical exploring. Through measurable investigation devices, for example, Analysis of Variance (ANOVA) and plots that uncovered the last chromatographic states of the strategy, the criticalness and communication impacts of these boundaries on the reaction factors (maintenance time and following component) were assessed. The chromatographic detachment was accomplished on Thermo Hypersil BDS RP C18 (250 × 4.6 mm, 5μ) section utilizing Buffer (pH 6.8): Acetonitrile (60:40v/v) as portable stage and discovery was finished utilizing Photo-Diode Array (PDA) identifier at 288 nm. The created fluvastatin sodium technique is direct with coefficients of relationship over a scope of 10-80μg/ml. The (R2) estimation of the connection coefficient is 0.999. The percent RSD for the strategy's exactness and accuracy was discovered to be under 2 percent. Investigations of Forced Degradation uncovered that the method was found to show security. The outcomes indicated that the strategy proposed is proper for the exact and precise assurance and detailing of fluvastatin sodium in mass.