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Method for detecting related substances of tirofiban hydrochloride injection

A technology for tirofiban and related substances, which is applied in the detection field of related substances of tirofiban hydrochloride injection, can solve the problems of peak tailing, long retention time of the main peak, failure to meet system requirements, etc., and achieve good accuracy, The effect of strong specificity and high sensitivity

Inactive Publication Date: 2020-04-10
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method requires that the tailing factor of the main peak shall not exceed 2.0, and the number of theoretical plates shall not be less than 7500. When screening according to this method, different brands of octadecylsilane bonded silica gel columns are selected, and the retention time of the main peak is very long, and the peak drags The tail is serious and cannot meet the system requirements

Method used

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  • Method for detecting related substances of tirofiban hydrochloride injection
  • Method for detecting related substances of tirofiban hydrochloride injection
  • Method for detecting related substances of tirofiban hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Tirofiban hydrochloride injection and its preparation

[0037] The preparation method is firstly dissolving citric acid and sodium citrate in 10-50% water to prepare a citric acid-sodium citrate buffer solution, then dissolving tirofiban hydrochloride and sodium alginate in water, and the two Mix the solution; adjust the pH, then filter, subpackage, sterilize, light check, and pack.

Embodiment 2

[0038] Embodiment 2 (comparative experiment 1)

[0039] Adopt the relevant substance detection method in the imported drug registration standard (standard number: JX20080265), select the chromatographic column of different brands to measure the obtained tirofiban hydrochloride injection of embodiment 1, record chromatogram, as figure 1 , figure 2 .

Embodiment 3

[0041] specificity test

[0042] System suitability test solution: take appropriate amount of tirofiban hydrochloride reference substance and impurity A reference substance, accurately weigh them respectively, add water to dilute and dissolve, and make a mixed solution containing about 25 μg of tirofiban and 0.5 μg of impurity A per 1 ml , as a system suitability test solution.

[0043] Blank solution: Measure 5ml of the blank excipient solution, put it in a 25ml measuring bottle, add water to dilute to the mark, shake well, filter, and take the subsequent filtrate.

[0044] Get the sample in embodiment 1 in right amount, dilute with water and make the solution that contains about tirofiban 25 μ g in every 1ml, as need testing solution.

[0045] Need test solution (oxidative damage): Accurately measure 2ml of sample solution, put it in a 20ml measuring bottle, add 2ml of 10% hydrogen peroxide solution, mix well, heat in a water bath at 95°C for 30 minutes, cool, dilute with w...

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Abstract

The invention belongs to the field of drug analysis. The invention relates to a method for detecting related substances of tirofiban hydrochloride injection, in particular to a method for detecting related substances of tirofiban hydrochloride injection by using high performance liquid chromatography, a chromatographic column taking octadecyl bonded silica gel as a filler is used as a stationary phase, a buffer solution with the pH value of 2.0-3.0 is used as a mobile phase A, an organic solvent is used as a mobile phase B, and the detection wavelength is 222-240nm. The detection method can effectively detect the related substances of the tirofiban hydrochloride injection, has strong specificity and high sensitivity, and is suitable for detecting the related substances of the tirofiban hydrochloride injection.

Description

technical field [0001] The invention belongs to the field of drug analysis and relates to a method for detecting related substances in tirofiban hydrochloride injection. Background technique [0002] Tirofiban hydrochloride was researched and developed by Merck Company of the United States. It was first listed in the United States in May 1998 and has been listed in many countries at present. Tirofiban hydrochloride is a highly efficient and highly selective GPⅡb / Ⅲa receptor antagonist, used for the treatment of patients with unstable angina or non-Q wave myocardial infarction, to prevent cardiac ischemic events, and also for coronary artery ischemia Coronary angioplasty or intracoronary atherectomy in patients with blood syndrome to prevent cardiac ischemic complications associated with sudden occlusion of treated coronary arteries. [0003] Impurities are an important factor affecting the quality of drugs. In the process of drug quality research, the structure of impuritie...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 张贵民崔芹芹
Owner LUNAN PHARMA GROUP CORPORATION
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