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Method for detecting maropitant citrate and related substances thereof

A technology related to substances and detection methods, applied in the field of drug analysis, can solve problems such as the lack of maropitant citrate, and achieve the effects of high sensitivity, convenient operation and high precision

Active Publication Date: 2021-03-26
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the problem that there is no detection method for maropitant citrate related substances in the prior art, the present invention provides a detection method for maropitant citrate and related substances thereof

Method used

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  • Method for detecting maropitant citrate and related substances thereof
  • Method for detecting maropitant citrate and related substances thereof
  • Method for detecting maropitant citrate and related substances thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The embodiment of the present invention provides a detection method of maropitant citrate and its related substances.

[0040] 1.1 Preparation of solution

[0041] Preparation of each impurity stock solution: take appropriate amount of impurity A, impurity B, impurity C, impurity D, impurity E, and impurity F reference substances, weigh them accurately, add 0.2% v / v triethylamine methanol solution to dissolve and dilute Prepare stock solutions of each impurity containing approximately 0.08 mg in 1 mL.

[0042] Preparation of test solution: Take an appropriate amount of maropitant citrate, add 0.2% v / v triethylamine in methanol solution to dissolve and dilute to make 1 mL containing 0.4 mg / mL of maropitant citrate ml of the test article.

[0043] Preparation of primary stock solution of reference substance: Accurately measure 2.0ml of each reference substance, put it in a 10mL volumetric flask, dissolve it with 0.2% v / v triethylamine methanol solution to the scale, sha...

Embodiment 2

[0097] This embodiment provides a detection method of maropitant citrate and its related substances, the conditions of high performance liquid chromatography:

[0098] Chromatographic column: CAPCELL PAK C18 (4.6×250mm) 5μm;

[0099] Flow rate: 1.0ml / min;

[0100] Detection wavelength: 222nm;

[0101] Column temperature, 38°C;

[0102] Concentration of the test solution: 0.4mg / ml;

[0103] Injection volume: 20μl;

[0104] Mobile phase A phase: 0.01mol / L dipotassium hydrogen phosphate solution (pH7.50), the preparation method is the same as in Example 1;

[0105] Mobile phase B phase: acetonitrile;

[0106] Mobile Phase C Phase: Methanol.

[0107] The gradient program conditions are the same as in Example 1.

[0108] Precisely measure 20 μL of the blank solvent, the mixed control solution of Example 1, and the solution of the test sample, inject into the liquid chromatograph respectively, and measure by the above-mentioned high-performance liquid chromatography condition...

Embodiment 3

[0114] This embodiment provides a detection method of maropitant citrate and its related substances, the conditions of high performance liquid chromatography:

[0115] Chromatographic column: CAPCELL PAK C18 (4.6×250mm) 5μm;

[0116] Flow rate: 1.0ml / min;

[0117] Detection wavelength: 222nm;

[0118] Column temperature, 42°C;

[0119] Concentration of the test solution: 0.4mg / ml;

[0120] Injection volume: 20μl;

[0121] Mobile phase A phase: 0.01mol / L dipotassium hydrogen phosphate solution (pH7.50), the preparation method is the same as in Example 1;

[0122] Mobile phase B phase: acetonitrile;

[0123] Mobile Phase C Phase: Methanol.

[0124] The gradient elution conditions were the same as in Example 1.

[0125] Precisely measure 20 μL each of the blank solvent, the mixed control solution of Example 1, and the solution of the test product, inject into the liquid chromatograph respectively, and measure by the above-mentioned high-performance liquid chromatography co...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for detecting maropitant citrate and related substances thereof. The detection method is a high performance liquid chromatography method, effective separation between main components and known impurities can be achieved by optimizing a solvent and chromatographic conditions of a to-be-detected solution, and the conditions of maropitant citrate and impurities thereof can be accurately, qualitatively and quantitatively detected. The detection method disclosed by the invention is good in chromatographic peak separation effect, high in sensitivity, relatively good in accuracy and reproducibility, simple in method and convenient to operate, fills up the blank in the field of detection of related substances of maropiracetam citrate, provides reliable guarantee for improving and better controlling the quality of a maropiracetam citrate product, and has a wide application prospect.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a detection method for maropitant citrate and related substances thereof. Background technique [0002] Maropitant citrate (English name: Maropitant Citrate; CAS number: 147116-67-4) is a neurokinin (NK1) receptor antagonist that can block substance P (a neurotransmitter related to vomiting) and The combination of receptors can effectively inhibit central nervous vomiting, peripheral nervous vomiting and vomiting caused by chemical factors. It is the first drug used to prevent and treat severe vomiting and motion sickness in dogs. The drug approved for marketing for the first time has the advantages of definite curative effect, fast absorption, high bioavailability, long-lasting drug effect and high safety, and has good clinical application value and market prospect. [0003] Impurities such as starting materials, intermediates, and by-products may be introduced during the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/74G01N30/30G01N30/32G01N30/86G01N30/88
CPCG01N30/02G01N30/34G01N30/74G01N30/30G01N30/32G01N30/8634G01N30/88G01N2030/324G01N2030/884G01N2030/8872
Inventor 李志伟张寒张子实袁月娇耿品杨倩倩
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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