Analytical Method for Simultaneous Estimation of Lumacftor and Ivacaftor in Pharamaceutical Dosage Form by Using RP-HPLC

Abstract

A simple, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Lumacaftor and Ivacaftor in bulk and pharmaceutical dosage forms in compliance with ICH Q2(R1) guidelines. Chromatographic separation was performed using an Agilent C18 column (4.5 × 150 mm, 5.0 µm) with a mobile phase of methanol and phosphate buffer (70:30 v/v) at a flow rate of 1.0 mL/min, and detection at 254 nm. The method exhibited excellent system suitability parameters, with a resolution of 5.23, tailing factors <2, and plate counts exceeding 2000 for both drugs. Linearity was established over the range of 20–100 µg/mL for Lumacaftor and 12.5–62.5 µg/mL for Ivacaftor, with correlation coefficients of 0.9996 and 0.9999, respectively. Precision studies showed %RSD values below 0.5%, and accuracy tests confirmed recoveries of 99.5% for Lumacaftor and 100.3% for Ivacaftor, all within the acceptance range of 98–102%. The limits of detection (LOD) were found to be 0.66 µg/mL and 0.44 µg/mL, while the limits of quantification (LOQ) were 2.28 µg/mL and 1.50 µg/mL for Lumacaftor and Ivacaftor, respectively. Robustness studies indicated no significant variation in performance with small deliberate changes in chromatographic conditions. The validated method is accurate, specific, sensitive, and reliable, making it suitable for routine quality control, regulatory compliance, and batch release testing of Lumacaftor and Ivacaftor in pharmaceutical formulations.