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Method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride

A technology based on dimethoxybenzoyl and Lizhong is applied in the field of pharmaceutical analysis to achieve the effects of strong specificity, high resolution and high system applicability

Active Publication Date: 2020-09-22
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no documented report on the detection method of 3,4-dimethoxybenzoyl chloride in itopride hydrochloride at present, and the present invention proposes a kind of 3,4-dimethoxybenzoyl chloride in itopride hydrochloride for the first time The detection method adopts octadecylsilane bonded silica gel as a fixed phase to carry out column chromatography on 3,4-dimethoxybenzoyl chloride in itopride hydrochloride, thereby realizing the 3,4-dimethoxybenzoyl chloride in itopride hydrochloride. Content determination of 4-dimethoxybenzoyl chloride

Method used

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  • Method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride
  • Method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride
  • Method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] (1) Experimental materials and instrument conditions

[0051] Experimental materials: aniline, manufacturer: Tianjin Damao Chemical Reagent Factory; acetonitrile, manufacturer: Xilong Science Co., Ltd.; phosphoric acid, manufacturer: ACROS; 3,4-dimethoxybenzoyl chloride, manufacturer: TCl ; Itopride hydrochloride, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.; ultrapure water, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.

[0052] Instruments: high performance liquid chromatography: 1260-П; electronic analytical balance: XSE205DU, GR-200; chromatographic column: Waters Nora-pak C18, 3.9×150 mm, 4.0 μm.

[0053] Inject the blank solution, the sensitivity solution, the reference substance solution and the test solution into the liquid chromatograph respectively, and record the chromatogram. The chromatographic conditions are as follows: Chromatographic column: use octadecylsilane bonded silica gel as filler; min; column temperature: 30°C; injection volume: 20...

Embodiment 2

[0069] Embodiment 2 Detection method system applicability test of the present invention

[0070] The system suitability is realized by measuring the S / N value of 3,4-dimethoxybenzoyl chloride in the sensitivity solution and the RSD of the peak area of ​​6 against 3,4-dimethoxybenzoyl chloride in the standard solution. It is required that the S / N value of 3,4-dimethoxybenzoyl chloride in the sensitivity solution and the RSD of the peak area of ​​3,4-dimethoxybenzoyl chloride in the reference solution should meet the acceptable standard.

[0071] Prepare blank solution, 3,4-dimethoxybenzoyl chloride stock solution, sensitivity solution and reference solution as described in Example 1. Under the chromatographic conditions described in Example 1, inject 1 needle of blank solution and 1 needle of sensitivity solution. Needle, reference substance solution 6 needles, get the chromatogram, such as figure 1 , figure 2 and image 3 , according to the formula conversion results are s...

Embodiment 3

[0073] Embodiment 3 Detection method specificity test of the present invention

[0074] The specificity of the method is that there is no interference to the detection by measuring the blank solution; the separation between 3,4-dimethoxybenzoyl chloride and adjacent peaks in the selective solution and the separation of 3,4-dimethoxybenzoyl chloride before and after sample addition achieved by the recovery rate. It is required that the blank solution should have no interference to the detection; the separation between 3,4-dimethoxybenzoyl chloride and adjacent peaks in the selective solution and the recovery rate of 3,4-dimethoxybenzoyl chloride before and after sample addition should meet acceptable standard.

[0075] Prepare blank solution, reference solution (3,4-dimethoxybenzoyl chloride positioning solution), test solution and selective solution as described in Example 1. After the system is balanced, inject 1 needle of blank solution, control 3 needles of product soluti...

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Abstract

The invention aims to provide a method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride. The method comprises the following steps: adding aniline into itopride hydrochloride to carrt out pre-column derivatization on 3, 4-dimethoxybenzoyl chloride; then, using octadecylsilane chemically bonded silica as a stationary phase to separate 3, 4-dimethoxybenzoyl chloride from itopride hydrochloride so as to confirm the residual amount of 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride. The system applicability, specificity, precision, detection limit, quantification limit, linearity and range, accuracy, durability and the like are verified to confirm the feasibility and effectiveness of the method. The method for detecting 3, 4-dimethoxybenzoyl chloride in itopride hydrochloride is provided for the first time, has the characteristics of high accuracy, high precision, good reproducibility, good stability, strong specificity and the like, and has the advantages ofshort time consumption, simple operation, low cost and the like.

Description

technical field [0001] The invention relates to an HPLC method for determining 3,4-dimethoxybenzoyl chloride in itopride hydrochloride, belonging to the technical field of drug analysis. Background technique [0002] The English name of Itopride Hydrochloride (CAS No.: 122892-31-3) is Itopride Hydrochloride, and the English name of its compound is N-[[4-(2-dimethylaminoethoxy)phenyl]methyl]-3,4-dimethoxy-benzamidehydrochloride. Itopride Hydrochloride Tablets was developed by Hokuriku Pharmaceuticals, Japan. It applied for a patent in 1989 and was first listed in Japan in 1995. my country successfully developed it at the beginning of this century and was approved by CFDA as a second-class new drug. Itopride hydrochloride is a new generation of benzamide prokinetic drugs, and it is a new drug with a mechanism of action that is not completely the same as that of existing prokinetic drugs. The trade name of Itopride Hydrochloride Tablets is Elthon, and Itopride Hydrochloride c...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34
Inventor 谢金昌顾琼汤伟彬王晴晴
Owner 珠海润都制药股份有限公司
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