Implementation of analytical quality by design and green chemistry principles to develop an ultra-high performance liquid chromatography method for the determination of Fluocinolone Acetonide impurities from its drug substance and topical oil formulations.

An anti-inflammatory skin condition is treated with fluocinolone acetonide (FLA), a synthetic corticoid. The current study aims to develop a stability-indicating UPLC method for the determination of impurities present in fluocinolone acetonide and its topical oil formulation. The method development was performed by implementing Analytical Quality by Design (AQbD) and green chemistry principles. A detailed risk assessment was conducted based on the cause-and-effect relationship. d-optimal split-plot design was employed to screen the critical method parameters (CMPs). The central composite design (CCD) was employed to optimize the final method conditions. p-values for the model and lack of fit were <0.0001 and >0.05, respectively, which indicates the best fit statistical model for the studied responses (peak resolutions R1 - R5). The critical method attributes (CMAs) and CMPs such as the ratio of ACN: Water in mobile phase-B as 600:400 (v/v), the ratio of mobile phase-A & B in initial gradient program as 60:40, flow rate as 0.3 mL min

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Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.