Pasala Sandhya Mounika, Rameeja Pattan*
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, Nellore
A simple, fast, accurate, precise, reproducible Stability indicating Reverse phase High performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Lumacaftor and Ivacaftor in Bulk and pharmaceutical dosage form. Chromatographic separation was done by using Agilent Eclipse XDB-C8 column having dimension of(4.6×150mm,5µm).Mobile phase containing 0.1% O.P.A and methanol in the ratio of 30:70 was pumped through column at a flow rate of 1ml/min. Temperature was maintained at 25°c.Optimized wavelength for Lumacaftor and Ivacaftor was 280 nm. Retention time of Lumacaftor and Ivacaftor were found to be 1.8&2.6 min. Percentage purity of Lumacaftor and Ivacaftor was found to be 100.19% and 101.45% respectively. System suitability parameters for Lumacaftor and Ivacaftor such as Theoretical plates are 4725.92&6256.39, Tailing factor are 1.46&1.29, resolution was found to be 3.18. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines (ICH, Q2 (R1)). Mean recovery was found to be 100.39% &100.39% respectively. Correlation coefficient (r2) was found to be 0.999&0.999, % RSD for Precision are 0.2 and 0.7 respectively. LOD, LOQ values of Lumacaftor are 3.07&10.09, Ivacaftor are 2.95 &9.93 respectively. Lumacaftor and Ivacaftor were subjected to stress conditions like Acidic, Alkaline, Oxidation, Photolysis and Thermal degradation. Hence the developed method can be successfully employed for the routine analysis of Lumacaftor and Ivacaftor in bulk and pharmaceutical dosage forms.
Key words: Lumacaftor, Ivacaftor, RP-HPLC, Method development, Validation.