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Quantitative analysis method of acotamine in human plasma

A technology of acotiamide and quantitative analysis, applied in the field of biological analysis, can solve the problem of unreported quantitative detection, and achieve the effect of satisfying the recovery rate, strong specificity and high stability

Inactive Publication Date: 2019-05-31
NANJING UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there is no report on the quantitative detection of acotiamide in the subject and its application in the clinical phase I bioequivalence test.

Method used

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  • Quantitative analysis method of acotamine in human plasma
  • Quantitative analysis method of acotamine in human plasma
  • Quantitative analysis method of acotamine in human plasma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: a kind of quantitative analysis method of acotiamide in human plasma

[0056] 1. Experimental materials and instruments

[0057] 1. Drugs and reagents: acotiamide hydrochloride (TLC); acotiamide hydrochloride-d6 (internal standard, TLC); acetonitrile (chromatographically pure, Merck); methanol (chromatographically pure, Merck); formic acid (chromatographic grade, Aladdin); Isopropanol (chromatographic grade, Yonghua Chemical Technology (Jiangsu) Co., Ltd.); Ammonium acetate (chromatographic grade, Aladdin); Ethyl acetate (chromatographically pure, Merck); tert-butyl methyl ether (chromatographically pure, Alfa); Ultrapure water (homemade, Millipore).

[0058] 2. Instruments: See Table 6 below for the names and specifications of specific instruments.

[0059] Table 6 Names and Specifications of Specific Instruments

[0060]

[0061]

[0062] 2. Liquid conditions

[0063] 1. Liquid chromatography conditions

[0064] Chromatographic column: Zorbax ...

Embodiment 2

[0140] Example 2: Quantitative analysis of acotiamide in human plasma using liquid-liquid extraction methods under different conditions

[0141] 1. Preparation of acotiamide working solution and internal standard working solution

[0142] Accurately weigh 1.007mg of acotiamide reference substance, after calculating the mass correction coefficient, add 0.878mL of methanol to prepare the acotiamide stock solution with a concentration of 1.00mg / mL, and use the acotiamide stock solution with Dilute the methanol-water solution with a volume ratio of 1:1 to a gradient of 0.4000ng / mL, 1.000ng / mL, 2.000ng / mL, 4.000ng / mL, 20.00ng / mL, 100.0ng / mL, 500.0ng / mL, 1000ng Acotiamide working solution at 1.200ng / mL, 1800ng / mL, 2000ng / mL; Repeat the above steps once to prepare acotiamide parallel working solution with gradient concentration of 1.200ng / mL, 60.00ng / mL, 1600ng / mL ; Preparation of internal standard (acotiamide-d6) standard solution: Accurately weigh 1.078 mg of acotiamide-d6 referen...

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Abstract

The invention relates to a quantitative analysis method of acotamine in human plasma, and belongs to the field of biological analysis. Protein precipitation is employed to process human plasma samples, alcodamine-d6 is taken as an internal standard to employ a high-performance liquid chromatography-mass spectrometry (UPLC MS / MS) method to detect the content of the acotamine in the human plasma. The detection method is high in sensitivity, high in specificity and high in stability, has the recovery rate up to 90%, can meet the requirements of the recovery rate and can improve the detection efficiency. Besides, the detection method is good in reproducibility and short in analysis time, can meet the requirements for the detection of the concentration of acetalamine in human plasma and can beused for pharmacokinetic study and bioequivalence study of the acotiamide tablet.

Description

technical field [0001] The invention belongs to the field of biological analysis, and in particular relates to a method for quantitatively detecting the concentration of acotiamide in blood plasma by liquid chromatography-mass spectrometry (UPLC-MS / MS). Background technique [0002] Acotiamide is a drug used to treat functional dyspepsia. By inhibiting acetylcholinesterase to promote gastric motility, improve gastric accommodation disorders, and enhance gastric fundus expansion to treat postprandial fullness, upper abdominal distension and early satiety symptoms caused by functional dyspepsia. Within the dosage range of 50-800 mg, the C of the drug max and AUC last Roughly linear with dose. For healthy adult males in Japan, 100 mg was orally administered each time on an empty stomach, before or after a meal. Compared with fasting and postprandial, preprandial drug C max higher. C of Medication max It is 62.7% higher than that of medication on an empty stomach. In add...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N27/64
Inventor 杨雨菲孙莉莉
Owner NANJING UNIV OF TECH
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