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Method for determining concentration of lacidipine in blood plasma by adopting liquid chromatography-tandem mass spectrometry

A technology of tandem mass spectrometry and liquid chromatography, which is applied in the field of liquid chromatography-tandem mass spectrometry to determine the concentration of lacidipine in plasma, which can solve the problems of time-consuming concentration steps, poor sensitivity of detection methods, and long analysis time, so as to improve safety Effects of sex, dose reduction, and sensitivity enhancement

Inactive Publication Date: 2020-08-28
苏州必宜生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The clinical dosage of lacidipine is 4-8 mg per day, and the peak concentration of a single administration after taking 4 mg is 2-8 ng / ml, but the sensitivity of existing detection methods is poor, which is limited by the sensitivity of detection methods. In the research, the concentration of the drug in the blood is often increased by increasing the dose of the drug, so as to obtain complete pharmacokinetic parameters
An increase in the dose of the drug is likely to cause adverse effects on the body of the subject
In addition, the existing methods also have the characteristics of complex operation, time-consuming concentration steps, long analysis time, and poor signal-to-noise ratio.

Method used

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  • Method for determining concentration of lacidipine in blood plasma by adopting liquid chromatography-tandem mass spectrometry
  • Method for determining concentration of lacidipine in blood plasma by adopting liquid chromatography-tandem mass spectrometry
  • Method for determining concentration of lacidipine in blood plasma by adopting liquid chromatography-tandem mass spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Determination of lacidipine in plasma by liquid chromatography-tandem mass spectrometry

[0026] 1. Instrument:

[0027] Sciex's Triple Quad TM 6500 + Triple quadrupole tandem mass spectrometer and Analyst 1.6.3 data processing software; LC-30 high performance liquid chromatography system from Shimadzu Corporation, including DGU-20A5R degasser, LC-30AD infusion pump, SIL-30AC automatic sampling 器,CTO-20A column thermostat.

[0028] 2. Pretreatment of plasma samples:

[0029] Add 50 µL lacidipine to 50 µL plasma sample- 13 C 8 Internal standard solution (concentration of 50 ng / mL, solvent is a methanol: water mixture with a volume ratio of 50:50), then add 400 µL of acetonitrile, vortex for 10 minutes, and centrifuge at 3900 rpm for 10 minutes at 4°C. The supernatant after centrifugation was transferred to another 96-well plate. Take 10.0 µL of the supernatant for LC-MS / MS analysis.

[0030] 3. Preparation of standard series samples and quality control samples:

[00...

Embodiment 2

[0037] Example 2: Methodological verification

[0038] The methodological verification of the measurement method in Example 1 is as follows:

[0039] 1. Selectivity:

[0040] Analyze the selectivity of the evaluation method of blank plasma, hemolyzed plasma, hyperlipidemia plasma and the lower limit of quantification sample prepared by the blank plasma from 6 different sources.

[0041] The results show that endogenous substances do not interfere with lacidipine and lacidipine- 13 C 8 The determination.

[0042] 2. Standard curve:

[0043] Taking the theoretical concentration of Lassidipine as the abscissa (x), Lassidipine and Lassidipine- 13 C 8 The peak area ratio is the ordinate (y), the linear regression equation for regression analysis calculation, and the weighting factor W=1 / x 2 , Lacidipine plasma concentration range 0.025 ~ 10.0 ng . mL −1 The inner linear relationship is good. The typical standard curve regression equation is: y=0.392x+0.000911 (r=0.9968).

[0044] 3. Precisi...

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Abstract

The invention discloses a method for determining concentration of lacidipine in blood plasma by adopting liquid chromatography-tandem mass spectrometry, and belongs to the technical field of pharmaceutical analysis. The method for determining the concentration of lacidipine in human plasma by adopting the liquid chromatography-tandem mass spectrometry is established in the invention, after a plasma sample is treated through using a protein precipitation method, a Luna PFP chromatographic column is adopted for rapid gradient elution chromatographic separation, and detection is conducted throughusing a tandem quadrupole mass spectrometer. The ion reactions monitored by mass spectrometry are as follows: m / z473.5 to 354.3(lacidipine) and m / z481.4 to 362.3(lacidipin-13C8). By adopting the method disclosed by the invention, the rapid and sensitive detection of lacidipine in the blood plasma can be realized, and the method can be applied to the bioequivalence research of lacidipine imitationmedicines.

Description

Technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining the concentration of lacidipine in plasma by liquid chromatography-tandem mass spectrometry. Background technique [0002] Lacidipine (Lacidipine, Lac) is a third-generation dihydropyridine calcium antagonist. Its antihypertensive effect is mild and long-lasting, with low dosage and small side effects. It is clinically classified as a treatment for mild to moderate essential hypertension (EH) One of the drugs of choice. [0003] During the development of lacidipine generic drugs, clinical bioequivalence studies are required to compare the exposure and absorption of generic drugs and original drugs in humans. Therefore, it is necessary to determine the concentration of lacidipine in the blood. The clinical dosage of lacidipine is 4-8mg per day, and the peak concentration of a single dose after taking 4mg is 2-8ng / ml. However, the sensitivity of the existi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/724G01N30/8675
Inventor 祁慧昕孙叶顾琴
Owner 苏州必宜生物科技有限公司
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