Integrated Analytical Quality by Design Approach for the Development and Validation of Liquid Chromatography Method for Simulataneous Estimation of Sulfadoxane and Pyrimethamine

Abstract

This research evaluates a validated chromatographic method for analyzing sulfadoxine and pyrimethamine. A quadratic model was most effective for retention time analysis (p < 0.0001). System suitability met regulatory standards for resolution, theoretical plates, and tailing. The method was validated for assay, linearity, precision, intermediate precision, accuracy, LOD, and LOQ. Assay values were 99.79% (sulfadoxine) and 99.52% (pyrimethamine). Linearity showed strong correlation (r = 0.9996 and 0.9993, respectively). Precision was excellent (%RSD<1), and accuracy fell within 98–102%. LODs were 0.5µg/mL and 0.2µg/mL, while LOQs were 1.9 µg/mL and 0.8µg/mL. The method proved robust under varied conditions and is suitable for concurrent formulation analysis.