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Method for detecting p-hydroxybenzaldehyde in itopride hydrochloride

A technology of p-hydroxybenzaldehyde and itopride hydrochloride, which is applied in the field of medical analysis and achieves the effects of good stability, strong specificity and high resolution

Active Publication Date: 2020-09-18
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

[0004] At present, there is no detection method for p-hydroxybenzaldehyde in itopride hydrochloride. As a pharmaceutical industry, it is very necessary to strictly control the content of impurities in products , help to optimize the synthesis process and quality control of drugs, study the detection method of p-hydroxybenzaldehyde in itopride hydrochloride, and provide a good reference for evaluating the quality of itopride hydrochloride and its synthetic intermediates, It also provides a technical basis for optimizing the synthesis process of itopride hydrochloride, and is of great significance for determining the adverse reactions caused by p-hydroxybenzaldehyde in itopride hydrochloride

Method used

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  • Method for detecting p-hydroxybenzaldehyde in itopride hydrochloride
  • Method for detecting p-hydroxybenzaldehyde in itopride hydrochloride
  • Method for detecting p-hydroxybenzaldehyde in itopride hydrochloride

Examples

Experimental program
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Effect test

Embodiment 1

[0045] (1) Experimental materials and instrument conditions

[0046]Experimental materials: Potassium dihydrogen phosphate, manufacturer: Guangdong Guanghua Technology Co., Ltd.; acetonitrile, manufacturer: Xilong Science Co., Ltd.; p-Hydroxybenzaldehyde, manufacturer: McLean; itopride hydrochloride, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.; ultrapure water, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.

[0047] 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.

[0048] Inject the blank 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; Temperature: 35°C; Injection volume: 20μl; Running time: 25min; Detection wavelength: 284nm; Mobi...

Embodiment 2

[0061] Embodiment 2 detection method system applicability test of the present invention

[0062] System suitability is achieved by measuring the RSD of the peak area of ​​p-hydroxybenzaldehyde in the reference solution. Requirement 6 The RSD of the peak area of ​​p-hydroxybenzaldehyde in the reference solution should meet the acceptable standard.

[0063] Prepare blank solution, p-Hydroxybenzaldehyde stock solution and reference substance solution as described in Example 1, under the chromatographic conditions described in Example 1, enter 1 needle of blank solution, 6 needles of reference substance solution, obtain chromatogram, as figure 1 with figure 2 , according to the formula conversion results are shown in the table below:

[0064]

Embodiment 3

[0065] Embodiment 3 Detection method specificity test of the present invention

[0066] The specificity of the method is achieved by determining that the blank solution does not interfere with the detection; the separation between p-hydroxybenzaldehyde and adjacent peaks in the selective solution and the recovery rate of p-hydroxybenzaldehyde before and after sample addition. It is required that the blank solution should not interfere with the detection; the separation between p-hydroxybenzaldehyde and adjacent peaks in the selective solution and the recovery rate of p-hydroxybenzaldehyde before and after sample addition should meet the acceptable standard.

[0067] Prepare blank solution, reference solution (p-hydroxybenzaldehyde positioning solution), test solution and selective solution as described in Example 1. After the system is balanced, inject 1 needle of blank solution, 3 needles of reference solution, and test 1 needle of product solution, 3 needles of selective sol...

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Abstract

The invention provides a method for detecting p-hydroxybenzaldehyde in itopride hydrochloride. 4-[(2-dimethylamino) ethoxy] benzylamine is a key intermediate for synthesizing itopride hydrochloride; p-hydroxybenzaldehyde is a starting material for synthesizing 4-[(2-dimethylamino) ethoxy] benzylamine; therefore, p-hydroxybenzaldehyde may not react completely in the process of synthesizing 4-[(2-dimethylamino) ethoxy] benzylamine and remains in 4-[(2-dimethylamino) ethoxy] benzylamine; further, the p-hydroxybenzaldehyde is possibly introduced into an itopride hydrochloride finished product; inorder to detect the content of p-hydroxybenzaldehyde in itopride hydrochloride, the invention provides a liquid chromatography detection method of p-hydroxybenzaldehyde in itopride hydrochloride for the first time, and the liquid chromatography detection method has the characteristics of high accuracy, high precision, good reproducibility, good stability, strong specificity and the like, and has the advantages of short time consumption, simple operation, low cost and the like.

Description

technical field [0001] The invention relates to the technical field of medical analysis, in particular to a method for detecting p-hydroxybenzaldehyde in itopride hydrochloride. Background technique [0002] Itopride hydrochloride was developed by Japan's Hokuriku Pharmaceutical Co., Ltd. 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. [0003] The invention provides a method for testing p-hydroxybenzaldehyde in itopride hydrochloride, 4-[(2-dimethylamino)ethoxy]benzylamine is a key intermediate for synthesizing itopride hydrochloride, and p-Hydroxybenzaldehyde is the starting material for the synthesis of 4-[(2-dimethylamino)ethoxy]benzylam...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884Y02A50/30
Inventor 谢金昌顾琼刘凤汤伟彬王晴晴
Owner 珠海润都制药股份有限公司
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