METHOD DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TEZACAFTOR , DEUTIVACAFTOR AND VANZACAFTOR IN BULK AND PHARMACEUTICAL DOSAGE FORM

AbstractA simple, rapid, precise, sensitive and reproducible Ultra performance liquid chromatography(UPLC) method has been developed for the quantitative analysis of Deutivacaftor, Tezacaftorand Vanzacaftor in pharmaceutical dosage form. Chromatographic separation ofDeutivacaftor, Tezacaftor and Vanzacaftor was achieved on Waters Acquity UPLC system,by using X-Bridge C18 (50 x 4.6mm, 2.1μm) column and the mobile phase containingAcetonitrile and Ammonium format pH-3.0/OPA in the ratio of 30:70% v/v. The flow ratewas 0.5 ml/min; detection was carried out by absorption at 223nm using a photodiode arraydetector at ambient temperature. The number of theoretical plates and tailing factor forDeutivacaftor, Tezacaftor and Vanzacaftor were NLT 2000 and should not more than 2respectively. % Relative standard deviation of peak areas of all measurements always lessthan 2.0. The proposed method was validated according to ICH guidelines. The method wasfound to be simple, economical, suitable, precise, accurate & robust method for quantitativeanalysis of Deutivacaftor, Tezacaftor and Vanzacaftor and study of its stability.