Utilizing QbD, a precise and innovative RP-HPLC technique was developed for Setmelanotide quantification. Design of Experiments (DOE) facilitated multivariate optimization, exploring the interplay between responses and independent variables through a polynomial equation. This optimization, aided by Design Expert software and Central Composite Design, finely adjusted Critical Method Parameters (CMPs). Chromatographic separation was executed on the X-Bridge C18 column measures 150 mm in length and 4.6 mm in diameter, featuring a particle size of 3.5 µm at 30°C. Optimized parameters comprised a mobile phase of 60 portions 0.1% Ortho phosphoric acid (OPA) & 40 portions of acetonitrile in volume/volume proportion at pH 3, achieving a desirability score of one. Detection at 225 nm with a flow rate of 0.8 ml/min disclosed a retention time of 2.271 minutes. Method validation aligned with ICH Q2(R1) guidelines, confirming the statistical significance of the chosen model via ANOVA (p=0.05). Two-dimensional contour plots effectively illustrated factor impacts and interactions on responses. Validation encompassed a comparison of actual and predicted values, all within acceptable ranges.
Key words: Setmelanotide, DoE Approach, Central Composite design, and ICH Q2 (R1)
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