Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry

Abstract

Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.