Establishment and application of a method for the determination of plasma concentration of delamanid
- VernacularTitle:德拉马尼血药浓度测定方法的建立及应用
- Author:
Qiaoyan DING
1
;
Huan ZHANG
1
;
Lihua MA
1
;
Sisi LI
1
;
Yu ZHANG
1
;
Ming ZHOU
1
Author Information
1. Dept. of Pharmacy，Pulmonary Hospital of Wuhan，Wuhan 430030，China
- Publication Type:Journal Article
- Keywords:
delamanid;
plasma concentration;
multidrug resistant tuberculosis;
LC-MS/MS
- From:
China Pharmacy
2022;33(24):3029-3033
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish and apply a method for the determination of plasma concentration of delamanid （DLM）. METHODS After plasma samples were treated with methanol precipitation， LC-MS/MS was adopted to determine the plasma concentration of DLM. The chromatographic column was Phenomenex SynergiTM Fusion-RP with mobile phase of methanol-0.1% formic acid solution （gradient elution）. The column temperature was 40 ℃ ， the flow rate was 0.3 mL/min， and the sample size was 1 μL. The ion source was electrospray ion source， and positive ion scanning was carried out in multi-reaction monitoring mode. The DLM ion pair used for quantitative analysis was m/z 535.0→352.0. The plasma concentration of DLM in 6 multidrug resistant tuberculosis （MDR-TB） patients were determined by the LC-MS/MS method. RESULTS The linear range of DLM was 0.05-8 μg/mL （r＝0.999 5）， and the lowest limit of quantitation was 0.05 μg/mL. RSDs of intra-batch and inter-batch precision were all less than 10%. The accuracy ranged 92.7%-104.9%. Average matrix effect was 94.3%-107.5%. Average recoveries were 93.2%-98.1%. The plasma concentration of DLM in 6 MDR-TB patients ranged from 0.61-2.76 μg/mL， with an average of （1.67± 0.74） μg/mL. CONCLUSIONS The established LC-MS/MS analysis method has good specificity， high sensitivity， accuracy and precision， and can be used to determine DLM plasma concentration in MDR-TB patients.
