Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN BULK AND PHARMACEUTICAL DOSAGE FORM

G. Indira Priyadarshini*, V. Mounika and G. Anjani, B. Sowmya

ABSTRACT

A simple, precise, accurate, sensitive, reliable and cost effective Stability indicating RP-HPLC method was developed and validated for the estimation of Tezacaftor and Ivacaftor in Bulk and pharmaceutical dosage form. Chromatographic separation was done by using a Phenomenex C18 column (4.6×250mm, 5μm). Mobile phase containing 0.2% TEA (pH 3.5), methanol and acetonitrile in the ratio of 40:50:10v/v was pumped through column at a flow rate of 1ml/min in isocratic mode. Temperature was maintained at Ambient. Optimized wavelength for Tezacaftor and Ivacaftor was 259 nm. Retention time of Tezacaftor and Ivacaftor were found to be 4.916 and 2.891 min respectively. The linearity was established over the concentration ranges of 20–100 μg/ml and 30–150 μg/ml with correlation coefficient (R2) 0.999 for both Tezacaftor and Ivacaftor. % RSD for Intra-day Precision for Tezacaftor and Ivacaftor were 0.6 and 0.7 respectively. % RSD for Intermediate Precision for Tezacaftor and Ivacaftor were 0.8 and 0.9 respectively. Mean % recovery was found to be 99.36% and 99.27% respectively. S/N ratio values of LOD, LOQ for Tezacaftor were 2.98 & 10.02, for Ivacaftor were 3.04 & 9.96 respectively. Percentage assay of Tezacaftor and Ivacaftor was found to be 99.69 and 100.21 respectively. Tezacaftor and Ivacaftor were subjected to stress conditions like Acidic, Alkaline, Oxidation, Thermal and Photo degradation and results showed that Tezacaftor was more sensitive towards alkaline degradation and Ivacaftor was more sensitive towards photo degradation. The % degradation results were within the limits. Hence the developed method can be successfully employed for the routine analysis of Tezacaftor and Ivacaftor in bulk and pharmaceutical dosage forms.

Keywords: Tezacaftor, Ivacaftor, RP-HPLC, Validation and Stability indicating.