Development And Validation of a Stability-Indicating RP-HPLC Method For Quantification of Iptacopan, A Complement Factor B Inhibitor, In Drug Substance and Pharmaceutical Formulations

Abstract: A simple, rapid, and reliable RP-HPLC method was proposed for the quantification of iptacopan in bulk drug and pharmaceutical dosage forms. Separation was achieved on C18 column using methanol and acetonitrile (60:40, v/v) at isocratic flow rate of 1.0 mL/min over 5 min runtime. The method produces sharp and well-resolved peak with 2.03 min retention time. It displays excellent specificity, with no interference from excipients. System suitability results were within acceptable limits, with tailing factor of 0.97 and 4732 theoretical plates indicates good column efficiency. The method demonstrates high sensitivity, with LOD and LOQ values of 0.15 µg/mL and 0.5 µg/mL, respectively. A strong linear response was noticed over 5-300 µg/mL (r² = 0.9994). Precision was proved with %RSD values of 0.17 (intra-day) and 0.84 (inter-day), while accuracy was observed in the range of 98.61% to 100.80%. The method remains stable under small deliberate variations proves its robustness and ruggedness. The forced degradation studies showsmoderate degradation under peroxide (9.65%), acidic (7.27%), and basic (7.35%) conditions, while drug remains stable under thermal (2.52%) and photolytic (2.08%) stress. No interference from degradation products was observedproves its stability-indicating capability. The assay was noticed to be 99.04% and demonstrates suitability for routine quality and stability assessment of Iptacopan.