A sensitive, heart-cutting, two-dimensional liquid chromatography–tandem mass spectrometry method for the determination of mometasone furoate in human plasma: Application for a bioequivalence study in nasal spray formulations

• Autorzy: Yang Leting , Yang Hongyi , Xie Huiru , Liu Hui , He Gangmin , Zhong Wenjing , Wang Ling

Identyfikatory

DOI

10.1556/1326.2022.01088

• Języki publikacji: EN

Abstrakty

EN

We developed and validated a sensitive, heart-cutting, two-dimensional liquid chromatography–tandem mass spectrometry (2D-LC‒MS/MS) method to determine the concentration of mometasone furoate in human plasma after nasal spray administration. Isotopically labeled mometasone furoate-13¹³C,d₆ was used as an internal standard (IS). Plasma samples were prepared using a solid-phase extraction (SPE) method. With this 2D-LC strategy, the analytes were trapped in the first dimension (1D) column, and only judiciously selected portions of the 1D effluent were transferred to the second dimension (2D) column for further separation to obtain high-resolution information. MS/MS quantification was performed in positive ionization mode via multiple-reaction monitoring (MRM). This analytical method was fully validated according to related regulatory guidance, and the results showed that the method is robust and sensitive enough for pharmacokinetic investigation of mometasone furoate with satisfactory linearity from 0.25 to 30 pg mL⁻¹. This method was successfully applied to a bioequivalence (BE) study of mometasone furoate aqueous nasal sprays in healthy volunteers.

Słowa kluczowe

EN

heart-cutting bidimensional liquid chromatography; LC‒MS/MS; mometasone furoate; nasal spray; bioequivalence

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2024
• Tom: Vol. 36, no. 1
• Strony: 14--22
• Opis fizyczny: Bibliogr. 15 poz., rys., tab., wykr.

Twórcy

autor

Yang Leting

• Chengdu Finelyse Pharmaceutical Technology Co., Ltd., Chengdu, China

autor

Yang Hongyi

• Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry, Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy, Sichuan University, Chengdu, China

autor

Xie Huiru

• Chengdu Finelyse Pharmaceutical Technology Co., Ltd., Chengdu, China

autor

Liu Hui

• Chengdu Finelyse Pharmaceutical Technology Co., Ltd., Chengdu, China

autor

He Gangmin

• Sichuan Purity Pharmaceutical Co., Ltd., Chengdu, China

autor

Zhong Wenjing

• Sichuan Purity Pharmaceutical Co., Ltd., Chengdu, China

autor

Wang Ling

• Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry, Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy, Sichuan University, Chengdu, China

• https://orcid.org/0000-0003-3220-6065

Bibliografia

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