Determination of the concentration of benidipine hydrochloride in human plasma by UPLC-MS/MS
10.13699/j.cnki.1001-6821.2023.24.022
- VernacularTitle:用UPLC-MS/MS法测定人血浆中盐酸贝尼地平的浓度
- Author:
Meng-Ran ZHAO
1
,
2
;
Le YANG
;
Yan-Jing ZHANG
;
Bin-Liang TONG
;
Qian-Qian YANG
;
Yun-Li ZHAO
Author Information
1. 沈阳药科大学药学院,辽宁沈阳 110000
2. 河北医科大学第一医院临床药学部,河北石家庄 050000
- Keywords:
benidipine;
ultra performance liquid chromatography/tandem mass spectrometry;
plasma concentration;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2023;39(24):3648-3652
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop an ultra performance liquid chromatography/tandem mass spectrometry(UPLC-MS/MS)method for the determination of benidipine in human plasma and apply it to the pharmacokinetics study of healthy volunteers.Methods Human plasma samples were pretreated with ethyl acetate extraction.The chromatographic column was Shim-pack XR-ODS Ⅲ(1.6 μm,2.0 mm × 50.0 mm),The mobile phase consisted of water(5 mmol·L-1 ammonium acetate)-acetonitrile with a isocratic elution at a flow rate of 0.3 mL·min-1.Detection was performed using an electrospray ionization source operating in positive ion multiple reaction monitoring mode,and d5 isotope of benidipine hydrochloride was used as the internal standard.To validate the method,specificity,linearity,quantification limit,precision,recovery,stability and matrix effect were determined.Results Benedipine had a good linear relationship(r＞0.999)in the concentration range of 0.01-15.00 ng·mL-1,the extraction recovery was 78.21％-83.14％,the precision relative standard deviation was less than 6.42％,and the stability was good.No significant matrix effects were found during the determination.Six healthy volunteers took one tablet of benidipine hydrochloride(8 mg)orally for two times,the mean T1/2,Tmax and Cmax of benidipine hydrochloride orally administered to subjects were(4.57±2.92)h,(1.08±0.52)h and(7.28±1.87)ng·mL-1,respectively.Conclusion The method has high sensitivity,high efficiency,good accuracy and simple operation,which can be used for the pharmacokinetics and bioequivalence study of benidipine.
