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Method for measuring concentrations of sacubitril, desethyl sacubitril and valsartan in human plasma

A technology of ethyl sacubitril and sacubitril, which is applied in the field of detecting drug concentration in human plasma, can solve problems such as lack, and achieve the effects of good peak shape, high response signal and simple operation

Active Publication Date: 2019-07-19
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there is a lack of a method in the prior art that can quickly detect the three substances of sacubitril, desethyl sacubitril and valsartan, and is friendly to equipment and technicians

Method used

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  • Method for measuring concentrations of sacubitril, desethyl sacubitril and valsartan in human plasma
  • Method for measuring concentrations of sacubitril, desethyl sacubitril and valsartan in human plasma
  • Method for measuring concentrations of sacubitril, desethyl sacubitril and valsartan in human plasma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] Example 1: Determination of sacubitril, desethylsacubitril and valsartan in plasma samples

[0102] Liquid phase conditions: mobile phase: acetonitrile-0.1% formic acid aqueous solution (v / v, 60:40), flow rate: 0.4 ml / min, column temperature and sample chamber temperature are both 20°C.

[0103]Mass spectrometry conditions: TRIPLE QUAD 5500 triple quadrupole tandem mass spectrometer of AB Company (equipped with electrospray ionization ESI source, Analyst 1.6.3 software). Electrospray ionization (ESI), positive ion mode, multiple reaction detection mode (MRM), spray voltage 5500V, ion source temperature 550°C, curtain gas: 35psi, atomizing gas: 45psi, auxiliary gas: 40psi. The ion pairs, residence time, etc. are as follows:

[0104] Table 1. Mass Spectrometry Information for Analytes and Internal Standards

[0105]

[0106] Pretreatment of plasma samples: Precisely draw 100 μL of plasma sample (the fourth concentration point of the standard curve), put it into a 2ml...

Embodiment 2

[0108] Example 2: Influence experiment of different diluents

[0109] Detect according to the method of Example 1. When other experimental conditions are the same, use different diluents: pure water and 50% methanol water to dilute the 100 μL supernatant obtained from the pretreatment of the sample, respectively inject the sample for analysis, and record the chromatogram. See Figure 2-1 ~ Figure 3-3 . It can be seen from the chromatogram that when the diluent is the 80% methanol water used in Example 1, the peak shape is the best.

Embodiment 3

[0110] Example 3: Methodological Validation—Exclusive Experiment

[0111] Take blank plasma (no internal standard was added during the sample pretreatment process), blank plasma, the fourth concentration plasma sample of the standard curve, and the plasma collected 1.75 hours after fasting administration. figure, see Figure 4-1-A ~ Figure 7-3-B .

[0112] Among them, the retention time of AHU377 was 1.37min, the retention time of LBQ657 was 0.97min, the retention time of Valsartan was 1.18min, the peak appeared within 3min, and the impurities in the plasma did not interfere with the determination (the blank plasma Figure 5-1-A In the chromatogram, the analyte AHU377 exists in the chromatogram because the internal standard is impure, but the low content does not affect the subsequent detection of AHU377), and the specificity of this method is good.

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Abstract

The invention relates to a method for detecting the concentrations of drugs in human plasma. According to the method, a sample is pretreated by using a methanol protein precipitation method and then further diluted; and detection is carried out by using an ultra-high performance liquid chromatography-tandem mass spectrometry. The method provided by the invention is capable of detecting three substances such as sacubitril, desethyl sacubitril and valsartan at the same time, so that less damage is caused to chromatographic columns and instruments.

Description

technical field [0001] The present invention relates to a method for detecting drug concentrations in human plasma. In particular, the present invention relates to a method for determining the concentrations of sacubitril, desethylsacubitril and valsartan in human plasma by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS). Background technique [0002] Sacubitril-valsartan sodium, suitable for adults with chronic heart failure (NYHA class II-IV, LVEF≤40%) with reduced ejection fraction, can reduce the risk of cardiovascular death and heart failure hospitalization. In addition, sacubitril and valsartan sodium can replace angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, and can be used in combination with other heart failure treatment drugs. Sacubitril-valsartan sodium is a first-in-class dual-acting angiotensin receptor-enkephalinase inhibitor with a unique mode of action that enhances the heart's protective n...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72
CPCG01N30/02G01N30/06G01N30/72
Inventor 高娜于云鹏王小彦张瑞兴祁欢欢毕宇鑫
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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