Quality by Design Approach in HPLC Method Development and Validation of Iptacopn Pharmaceutical Dosage Form

Abstract

A simple, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Iptacopan in bulk and pharmaceutical dosage forms in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using an Inspire C18 column (150×4.6 mm, 5 µm) with a mobile phase comprising acetonitrile and trifluoroacetic acid (35:65 v/v) at a flow rate of 1.0 mL/min, and detection was carried out at 230 nm. The method demonstrated excellent system suitability, with a USP plate count of 4932.41 and a tailing factor of 1.22. Linearity was observed in the concentration range of 10–50µg/mL with a correlation coefficient (R²) of 0.999. Precision studies showed %RSD values of 0.7% for repeatability and 0.5% for intermediate precision, indicating high reproducibility. Accuracy, evaluated through recovery studies, yielded a mean recovery of 98.10%, within the acceptable range of 98–102%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.57 µg/mL and 1.98 µg/mL, respectively. Robustness studies confirmed that small deliberate changes in flow rate and mobile phase composition did not significantly affect method performance. The validated method meets all ICH criteria and is suitable for routine quality control analysis of Iptacopan in bulk and dosage forms, offering high sensitivity, reproducibility, and cost-effectiveness.