Sunday , 16 May 2021

Analytical Method Development and Validation for the Simultaneous Estimation of Ivacaftor and Lumacaftor in its Bulk and Pharmaceutical Dosage Forms

Satheesh1, Dr. D. Naresh2, P.Sowjanya3, Dr. Gampa Vijaya Kumar*2
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Department of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A new method was established for simultaneous estimation of Ivacaftor and Lumacaftor by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Ivacaftor and Lumacaftor by using Xterra C185µm (4.6*250mm)column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer(0.05M) pH4.6: ACN  (55:45%v/v)  (pH  was   adjusted  with  orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower software version-2. The retention times were found to be 2.399mins and 3.907mins. The % purity of Ivacaftor and Lumacaftor was found to be 100.7% and 101.4%respectively. The system suitability parameters for Ivacaftor and Lumacaftor such as the oretical plates and tailing factor were found to be 1.3, 5117.5 and 1.4,3877.3 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ivacaftor and Lumacaftor was found  in  concentration  range   of  1μg-5μg  and  100μg-500μg   and correlation coefficient (r2) was found to be 0.999and 0.999% mean recovery was found to be 100% and 100.5%, % RSD for repeatability was 0.2 and 0.4, %RSD for intermediate precision was 0.5and 0.1 respectively. The precision study was precise, robust and repeatable. LOD value was 2.95 and 3.04 and LOQ value was 9.87and10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Ivacaftor and Lumacaftor in API and Pharmaceutical dosage form.

Keywords: Ivacaftor, Lumacaftor, RP-HPLC

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