Vol. 6, Issue 1, Part A (2024)

Background: The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. From literature review and solubility analysis initial chromatographic conditions Mobile phases ortho phosphate acid buffer: Methanol 65:35 were set (Buff PH 3 adjusted with opa), symmetry C 18.1 (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. The retention times for Ivacftor and Lumacaftor was found to be 2.972 min and 3.548 min respectively.
Objective: The main objective of the simultaneous estimation of combined drug was to establish identity, purity, physical characteristics and potency of the drugs.
Materials and Methods: Symmetry C 18 column was used for the analysis and maintained buffer pH 3 with diluted OPA  and Methanol in the ration of 65:35  was running through column at 1.0 ml flow rate at ambient temperature and absorption maxima was observed at  254 nm.
Results: All the results obtained were precise, accurate and robust as per international conference on Harmonization (ICH) guidelines.
Conclusion: The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. From literature review and solubility analysis initial chromatographic conditions Mobile phase ortho phosph acid buff: Metha 65:35 were set (Buff PH 3 adjusted with opa), symmetry C 18.1 (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. As the metha content was increased Ivacftor and Lumaca got eluted with good peak symmetric properties. The retention times for Ivacftor and Lumaca was found to be 2.972 min and 3.548 min respectively.