DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN FORMULATIONS
Objective: Aim of the present research work was to develop a sensitive, rapid and accurate, stability-indicating RP-UPLC method for the simultaneous estimation of tezacaftor and ivacaftor in formulations.
Methods: The chromatographic separation of the mixture of tezacaftor and ivacaftor was attained in isocratic method utilizing a mobile phase of 0.1 % orthophosphoric acid and acetonitrile in the proportion of 50:50%v/v utilizing a HSS C18 column which has dimensions of 100×2.1 mm, 1.7 m particle size and the flow rate of 0.3 ml/min. The detection system was monitored at 292 nm wavelength maximum with 1.5 ml injection volume. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity and precision.
Results: The retaining time for tezacaftor and ivacaftor were achieved at 1.071 min and 0.530 min, respectively. Tezacaftor, ivacaftor and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The developed method was highly sensitive, rapid, precise and accurate than the earlier reported methods. The total run time was decreased to 2.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of tezacaftor and ivacaftor.
Conclusion: The projected method can be utilized for routine analysis in the quality control department in pharmaceutical trades.
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