ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IVACAFTOR AND LUMACAFTOR BY RP-HPLC METHOD

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Ivacaftor and Lumacaftor from bulk formulations. Chromatographic separation was achieved isocratically on a Waters Xterra C18 column (4.6 x 250mm, 5?m) using a mobile phase, Acetonitrile: Phosphate buffer pH adjusted to 4.6 with ortho phosphoric acid in the ratio of 45:55% v/v. The flow rate was 1 ml/min and effluent was detected at 255nm. The linearity was observed in the concentration range of 100-500?g/ml of Lumacaftor and 1-5?g/ml of Ivacaftor. Linear regression coefficient was not more than 0.999. The values of RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Ivacaftor and Lumacaftor. LOD was 2.95 and 3.04 and LOQ was 9.87 and 10 for Ivacaftor and Lumacaftor respectively. The results obtained on validation parameters met ICH and USP requirements. It inferred that the method found to be simple, accurate, precise and linear. The method was found to be having suitable applications in routine laboratory analysis with high degree of accuracy and precision. Key Words: Ivacaftor, Lumacaftor, Validation, Isocratically.