Analytical Method Development and Validation of Tezacaftor and Ivacaftor by RP-HPLC Method in Bulk and Marketed Formulation

Author(s): Theegala Ravali*, S. Marakatham, M. Sathish Kumar and RV. Valli Kumari**

Abstract: A RP-HPLC technique based assay procedure is developed, validated and applied for quantification of ivacaftor and tezacaftor simultaneously in tablet dosage forms. Procedure is based on separation and analysis of ivacaftor and tezacaftor in Kromosil C18 column with 0.1M KH2PO4: methanol (65:35 v/v) mixture as mobile phase. The elution time values for ivacaftor and tezacaftor were 3.128 min and 4.044 min, respectively. Linear ranges for ivacaftor and tezacaftor were 75-225 μg/ml and 50-150 μg/ml, respectively with regression coefficients of ˃0.9990. The sensitivity values were 0.056 μg/ml (LOD) and 1.819 μg/ml (LOQ) for ivacaftor and 0.405 (LOD) μg/ml and 1.351 μg/ml (LOQ). Validation parameters are tested as per guidelines of ICH and all values are well acceptable. The method was applied to tablet dosage forms with excellent percent assay values.

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