Methodological study and clinical application of HPLC-MS/MS for the determination of olverembatinib in the plasma of leukemia patients
10.12173/j.issn.2097-4922.202405061
- VernacularTitle:HPLC-MS/MS法测定白血病患者血浆奥雷巴替尼的方法学研究及临床应用
- Author:
Jinyan GUO
1
;
Wenli SUN
;
Rui LIU
;
Guangze LU
;
Hongxing LIU
;
Lei WANG
Author Information
1. 河北燕达陆道培医院检验医学科(河北廊坊 065201)
- Keywords:
Olverembatinib;
High-performance liquid chromatography tandem mass spectrometry;
Therapeutic drug monitoring;
Leukemia;
Methodological study;
Chinical application
- From:
China Pharmacist
2024;28(11):472-480
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high-performance liquid chromatography tandem mass spectrometry(HPLC-MS/MS)method for determining the plasma concentration of olverembatinib in leukemia patients,apply it to clinical drug monitoring,and provide reliable basis for rational drug use in clinical practice.Methods Ponatinib-d8 was used as an internal standard,and methanol was used to precipitate plasma proteins and extract olverembatinib.The chromatographic column was Welch Ultimate XB-C18 cloumn(50 mmx4.6 mm,5 μm),with a column temperature of 60 ℃.The mobile phase consisted of an aqueous solution(containing 0.1％formic acid+2 mmol/L ammonium acetate)-methanol solution(containing 0.1％formic acid),with a flow rate of 0.8 mL/min and gradient elution.Electrospray positive ion mode was used,with multiple reaction monitoring scanning.The quantitative ion pair of olverembatinib was m/z 533.3→260.1,the qualitative ion pair was m/z 533.3→433.3,and the internal standard ion pair was m/z 541.1 →260.2.The plasma samples of 40 leukemia patients taking olverembatinib were monitored and analyzed for concentration,and IBM SPSS Statistics 27.0 and OriginPro 2021 softwares were used for statistical analysis of the results.Results The linear range of olverembatinib was 1-250 ng/mL(r=0.998 0),the lower limit of quantification was 1 ng/mL,the extraction recovery rate was 100.28％～101.27％,the intra-day precision RSD was 1.15％～3.87％,and the inter-day precision RSD was 2.32％～3.68％.Conclusion This method is easy to operate,highly specific and sensitive,and can be used to determine the blood concentration of olverembatinib in leukemia patients.
