Analytical method development and validation for the estimation of Lumacaftor and Ivacaftor using RP-HPLC

Abstract

A simple and selective LC method is described for the determination of Ivacaftor and Lumacaftorintablet dosage forms. Chromatographic separation was achieved on a c₁₈ column using mobile phase consisting of a mixture of 45 volumes of acetonitrile and 55 volumes of mixed phosphate buffer with detection of 225 nm. Linearity was observed in the range 30-70 µg /ml for Ivacaftor(r² =0.997) and 40-80µg /ml for Lumacaftor (r² =0.998) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.

The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.