METHOD DEVELOPMENT AND VALIDATION OF IVACAFTOR IN BULK & PHARMACEUTICAL DOSAGE FORM BY UV-VISIBLE SPECTROPHOTOMETRY

Objective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitative estimation of drug - Ivacaftor in active pharmaceutical ingredient (API) form and in pharmaceutical dosage form Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of Cystic fibrosis drug Ivacaftor based on measurement of absorption at a wavelength maximum (lambda max) of 255 nm using Acetonitrile as solvent. Results: The method was validated in terms of, precision, linearity, accuracy, and robustness, LOD, LOQas per the ICH guidelines. The method was found to be linear in the range of 50-150% for Ivacaftor. The percentage recovery values were in the range of 99.9-100.9% for Ivacaftor at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Ivacaftor drug substances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of Ivacaftor drug substances. Conclusion: The developed method can be successfully applied for Ivacaftor routine analysis, quality control analysis, and also suitable for stability analysis of in API & its pharmaceutical dosage form as per the regulatory requirements.