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Method for detecting related substances in itopride hydrochloride preparation

A technology for itopride hydrochloride and related substances, which is applied to the detection of related substances in itopride hydrochloride preparations and the detection of related substances in medicines, and can solve the problems that cannot meet the needs of inspection, do not meet requirements, and do not meet the requirements. Peak and other issues

Active Publication Date: 2021-06-22
珠海润都制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The study found that the recovery rate of this method was low, only 84.5%. The chromatographic column recommended by the Pharmacopoeia (Kromasil C1 8, 4.6 mm X 250mm, 5μm) was used for detection, and the separation degree of impurity pH and itopride was 0.97 , replace the chromatographic column, the separation degree of impurity PH and itopride is still less than 1.2, which does not meet the requirements; the impurity IHD has no absorption when the detection wavelength is 258nm; when multiple samples are continuously detected, there will be no peak abnormalities Phenomenon, unable to meet the needs of inspection

Method used

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  • Method for detecting related substances in itopride hydrochloride preparation
  • Method for detecting related substances in itopride hydrochloride preparation
  • Method for detecting related substances in itopride hydrochloride preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1 detection method

[0063] (1) Instrument conditions and reagents

[0064] Instruments and conditions: high performance liquid chromatography: model: Agilent1260; chromatographic column: Thermo gold aQ C18, 4.6mm×250mm, 5μm; electronic analytical balance, pH meter, detection wavelength is 223nm, injection volume is 20μl, column temperature: 25°C; use 0.05mol / L potassium dihydrogen phosphate solution (adjust the pH value to 4.5 with dilute phosphoric acid or dilute potassium hydroxide solution) as mobile phase A, and use acetonitrile with a volume fraction of 90% as mobile phase B according to Table 1. Linear gradient elution.

[0065] Reagents and reference substances: as shown in Table 4.

[0066] (2) Test operation

[0067] ① Solution preparation:

[0068] Blank solution: 0.05mol / L potassium dihydrogen phosphate solution (adjust the pH value to 4.5 with dilute phosphoric acid or dilute potassium hydroxide solution)-90% acetonitrile (V:V=85: 15);

[00...

Embodiment 2

[0074] Embodiment 2 System suitability test

[0075] System suitability, 5 for the peak area RSD of itopride peak in the solution should not be greater than 2.0%, and the separation between the main peak and adjacent impurity peaks of the system suitability solution meets the requirements.

[0076] System suitability solution: take about 50 mg of itopride hydrochloride reference substance, accurately weigh it, put it in a 100ml measuring bottle, measure 1ml each of impurity IHD, PH, VA positioning solution, put it in the same 100ml measuring bottle, add diluent Appropriate shaking, sonication to dissolve itopride hydrochloride, add diluent to dilute to the mark, shake well, and obtain.

[0077] Need testing solution: get about 125 mg of itopride hydrochloride tablet sample powder (approximately equivalent to 50 mg of itopride hydrochloride), accurately weighed, put in a 100ml measuring bottle, add diluent and shake in an appropriate amount, and ultrasonically make itopride hyd...

Embodiment 3

[0081] Embodiment 3 sample test

[0082] Itopride hydrochloride tablets (batch number: 20190201; self-made) were tested according to the method of Example 1. The test results are as follows, which conform to the regulations of the Pharmacopoeia on the relevant substances of this product.

[0083]

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Abstract

The invention provides an improved method for detecting related substances in an itopride hydrochloride preparation, which is characterized in that a monopotassium phosphate solution is used as a mobile phase A, a 90% acetonitrile solution is used as a mobile phase B to carry out gradient elution, the detection wavelength is 223 nm, the volume ratio of the monopotassium phosphate solution to the acetonitrile solution in a blank solution is 85:15, the separation degree of the itopride, the impurity VA, the impurity IHD and the impurity PH peak is more than 1.2, the abnormal phenomenon of no peak appearance during the continuous test of a plurality of samples does not exist, the method verification results show that the method meets the related requirements, the method meets the detection requirements, and the related substances in the itopride hydrochloride preparation can be effectively detected.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a detection method for detecting related substances in medicines, and more particularly relates to a detection method for detecting related substances in itopride hydrochloride preparations. Background technique [0002] Itopride hydrochloride is a gastrointestinal prokinetic drug. The original tablet was approved in China in 2003. The trade name (middle) is Elthon. Dyspepsia symptoms caused by functional dyspepsia, chronic gastritis, etc.), including epigastric fullness, epigastric pain, loss of appetite, nausea and vomiting, etc. The chemical name of itopride hydrochloride is N-[4-[2-(N,N-dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide hydrochloride ( CAS number: 122892-31-3), the chemical structure is shown in formula I: [0003] [0004] According to its structure, its potential impurities are 3,4-dimethoxybenzoic acid (formula II), 4-[2-(dimethylam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/047
Inventor 黄俊鹏冯伟霞成秀连梁翠娟王赛倾关东谢斌焦慎超
Owner 珠海润都制药股份有限公司
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