Abstract

N. Md.  Akram*¹and  Dr. M. Umamahesh²

DOI : http://dx.doi.org/10.13005/ojc/330354

A New method was established for simultaneous estimation of Lumacaftor and Ivacaftor by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Lumacaftor and Ivacaftorby using Ineertsil ODS  column (4.6×250mm) 5µ, flow rate was 1ml/min, mobile phase ratio  (30:10:60v/v) ACN,Methanol,1ml of OPA in 1000ml waterpH 3 (pH  adjusted with triethylamine),detection wavelength used by WATERS HPLC Auto Sampler, Separation module 2695, UV detector 2489, Empower-software version-2. The retention times were found to be 3.101 mins and 4.205mins. The % purity of Ivacaftor and Lumacaftor were found to be 100.17 and100.39 respectively. The present analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Ivacaftor and Lumacaftorwas found in the concentration range 62.5µg/ml-312.5µg/mland 100µg/ml-500µg/mland correlation coefficient (R²)  be 0.999 and 0.999, % recovery was found to be 100.13 and 100.53, %RSD for repeatability  0.8 and 0.8, % RSD for intermediate precision was 0.7 and 0.6respectively. The precision study was precision, robustness and repeatability. It is a convenient, simple and quick method for the determination of Ivacaftor and Lumacaftorin its bulk and pharmaceutical dosage forms.

Ivacaftor; Lumacaftor; HPLC; Methanol; Acn.

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