Hplc Method Development And Validation Of Ivacaftor And Lumacaftor, Characterization Of Its Degradants By Lc-Ms/Ms

Abstract

Objective: An assay method was developed and validated for the simultaneous estimation of Ivacaftor and Lumacaftor using RP-HPLC. 

Methods: An effective chromatographic separation was achieved using Hyper clone 5µ BDS C18 130°A column of dimensions 250X4.6mm, 5μm, as a stationary phase.HSA pH-2.5/OPAand acetonitrile in 60:40 v/v was used as a mobile process with a rate of 1 ml/min and UV detection was carried outat 260nm, respectively. Isocratic chromatography at ambient temperature was performed.

Results: Ivacaftor and Lumacaftor were separated by a running time of around 10min,at 3.152min. and 6.932min. respectively. By injecting the norm six times, device suitability parameters were studied and the outcomes were well under the acceptance criteria. The linearity analysis was performed at levels ranging from 25% to 150% and the R² value was found to be 0.999.

Conclusion: Assay method validation was performed by using the marketed formulation and found to be within the limit. Degradation tests were conducted and the degradants were characterized by using LC-MS/MS.