فهرست نشریات علمی دسترسی آزاد ایران

ABSTRACT-Herein, we present the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the analysis of 1-(4-chlorophenyl) pyrrolidine-2,5-dione (CPS), an important intermediate and active pharmaceutical ingredient. CPS, also known as chlorophenyl pyrrolidine succinimide, consists of a chlorophenyl group, which enhances lipophilicity and receptor binding; a pyrrolidine ring, contributing to structural stability; and a succinimide moiety, which facilitates biological activity. The Box–Behnken Design (BBD), a type of response surface methodology, was employed to optimize chromatographic conditions, including the mobile phase composition, flow rate, detection wavelength, and other parameters, with a strong focus on sensitivity, clarity, accuracy, and robustness. The optimized RP-HPLC method achieved a favorable retention time of 4.567 minutes for CPS at a detection wavelength of 222 nm. The method demonstrated excellent linearity (r² = 0.9988), good accuracy (recovery range: 98–102%), and precision (%RSD < 2%). The specificity of the method was confirmed by the absence of interference from excipients and degradation products. The limits of detection (LOD) and quantification (LOQ) were calculated to be 0.1837 ppm and 0.5569 ppm, respectively. Stability studies under various stress conditions demonstrated that the method is stability-indicating and capable of separating CPS from its degradation products. This study highlights the effectiveness of the Box–Behnken Design in the systematic development of an RP-HPLC method and underscores the importance of the Quality by Design (QbD) approach in ensuring method reliability and regulatory compliance. Accurate, precise, and reproducible results were obtained by strictly adhering to ICH guidelines.