Implementation of QbD Approach To The Analytical Method Development and Validation For Sunroid and Deflazacort

Abstract

In today’s time rapid paced and highly competitive industrial surrounding, fast and robust HPLC method development becomes highly important. Chromatographic method develop- ment can be a time consuming and subjective process. QbD is an approach for a better product and process understanding. It creates a complete idea about the all the process parameters and can be used as a risk assessment tool. A rapid reversed-phase HPLC method has been devel- oped for the analysis of Sunroid. Software SAS JMP® has been used to optimize the column brand, column particle size, mobile phase ratio, injection volume and other HPLC conditions. The Statistical software as SAS JMP® used with the PLS (partial least square) mode. Defini- tive screening and fit model have been used to generate design space. In reference to the current prospects, the method was developed for Sunroid which is an anti-inflammatory steroidal drug and marketed by SUN Pharmaceuticals Industries Limited. The method was validated for different validation parameters as per the ICH guidelines. The method was also evaluated for a forced degradation study based on different stress parameters. The method uses isocratic elution from C18-thermo Hypersil Bds column, (250 mm × 4 mm%× 5 μm particle size) and acetoni- trile/water (45/55, % v/v) as the organic mobile phase with UV detection at 245 nm. Using these conditions, the validation results confirmed that the method is precise, accurate and linear at concentrations ranging from 0.05 mg/ml to 0.15 mg/mL. The recoveries ranged from 99% to 102% at concentrations from 0.05 mg/ml to 0.15 mg/mL for Sunroid The validation also confirmed the robustness of the method as predicted by SAS JMP. Eventually it indicates that the method performance can be understood and enhanced if essential, and a control strategy can be defined to manage risk and ensure the method performs as desired when validated and deployed.