Abstract

APPLICATION OF UV SPECTROPHOTOMETERIN METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION OF TEZACAFOR AND IVACAFTOR IN PHARMACEUTICAL DOSAGE FORM

Sonawane M. D.*, Gade S. T. and B. M. Narwate

Abstract

Two precise, simple, accurate, reproducible, rapid and economical UV spectrophotometric methods have been developed for simultaneous estimation of tezacaftor and ivacaftor in tablet dosage form by using ethanol as solvent. Method I is based on formation and solving of simultaneous equation method, known as vierodt’s method. tezacaftor and ivacaftor show absorbance maxima at 239 nm and 351 nm respectively, so absorbance was measured at the same wavelength for the estimation of tezacaftor and ivacaftor in tablet combination. Method II is based on principle of Q-analysis, known as absorbance ratio method. Absorbance was measured at 265 nm (isobestic point) and 274 nm (λmax of ivacaftor). tezacaftor and ivacaftor obeys beer’s law in the concentration range of 5 to 30 μg/ml. Percentage estimation of tezacaftor and ivacaftor in tablet dosage form by method I is 99 and 99.85 and by method II is 99 and 99.89 respectively with standard deviation ≤2. Methods are validated according to ICH guidelines and can be applied for routine analysis of drugs in tablet dosage form.

Keywords: Tezacaftor and ivacaftor.