Heudi, Olivier, Jain, Monish and Winter, Serge (2024) Highly sensitive LC-MS/MS method for the quantitative analysis of mometasone furoate in human plasma, method validation and application to clinical pharmacokinetic studies. Biomedical chromatography BMC., 38 (7). pp. 1-10.

Abstract

We report the development and the validation of a sensitive LC-MS/MS method for mometasone furoate (MF) analysis in human plasma. Plasma samples were processed through liquid-liquid extraction and analyzed by LC-MS/MS operating in positive mode using multiple reaction monitoring of transitions m/z 520.9.0 → 355.0 and m/z 525.8 → 355.0 for MF and the internal standard (IS), respectively. Separation was achieved at 1.0 mL/min on a C18 column using a gradient elution of mobile phase of 0.05% ammonia in water (phase A) and acetonitrile (phase B). The linear response range was 0.250 to 100 pg/mL using 1/x2 weighing factor. The intra- and inter-day accuracies (bias %) ranged between -3.1 and 18.9 % and from -2.8 to 16.3 %, respectively. The intra- and inter day precisions (CV %) range from 0.4 to 13.9% and 1.0 – 8.1 %, respectively. The CV (%) of the IS normalized matrix factor (MF) was below 15% and not affected in lipemic and hemolyzed plasmas. MF Normalized recoveries were consistent and reproducible with a CV% value of 6.0. The present method was successfully applied to the quantitative analysis of MF in clinical studies where MF, Indacaterol and Glycopyrronium were delivered as a fixed dose combination.

Item Type:	Article
Keywords:	Asthma; Mometasone Furoate; LC-MS/MS; validation and fixed dose combination, pharmacokinetic
Date Deposited:	05 Nov 2024 00:45
Last Modified:	05 Nov 2024 00:45
URI:	https://oak.novartis.com/id/eprint/52655