ISSN: 2249–9504
CAS CODEN: IJPCDX

A NOVEL STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ANALYSIS OF IVACAFTOR AND TEZACAFTOR IN PURE AND ITS PHARMACEUTICAL FORMULATIONS

Abstract

Author(s): M. Rama Ayyappa1*, G. Raveendra Babu1, C. Sushama1, M. Sowjanya2 and G. Lakshmana Murthy3

A novel stability-indicating RP-HPLC method for the simultaneous analysis of Ivacaftor and Tezacaftor in pure and its pharmaceutical formulations. Chromatographic separations were achieved in Shemadzu, Empower 2 software, module of separation is 2695, UV detector equipped with Kromisil C18 (150 x 4.6 mm, 5 µm) using mobile phase is water: acetonitrile, (50:50, v/v), detection wavelength at 292 nm. The Rt of Ivacaftor is 2.089 min and Rt of Tezacaftor is 2.434 min was found. The linearity ranges was 15-90 μg/ml and 10-60 μg/ml of Ivacaftor and Tezacaftor, respectively. All the validation parameters must be reached with acceptable limits. The proposed method was simultaneous analysis of Ivacaftor and Tezacaftor successfully applied in quality control labs.

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