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Method for determining content of genotoxic impurities of ligustrazine hydrochloride

A Ligustrazine hydrochloride and genotoxicity technology, which is applied in the field of determination of Ligustrazine hydrochloride genotoxic impurities, can solve the problems of not including genotoxic impurity determination methods, unable to fully reflect the product quality status, etc., to ensure effectiveness and consistency Reliability, stable measurement conditions, comprehensive effect monitoring

Pending Publication Date: 2020-05-12
HEFEI PINGGUANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The quality standard of ligustrazine hydrochloride is included in the second part of the "Chinese Pharmacopoeia" 2015 edition, in which there are only related substance detection items, and there is no genotoxic impurity detection method at present, which cannot fully reflect the quality status of the product; and the pharmacopoeia has not yet included this Determination method for genotoxic impurities in products

Method used

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  • Method for determining content of genotoxic impurities of ligustrazine hydrochloride
  • Method for determining content of genotoxic impurities of ligustrazine hydrochloride

Examples

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Effect test

Embodiment 1

[0027] A method for measuring the genotoxic impurity content of ligustrazine hydrochloride, which adopts liquid chromatography-mass spectrometry, and its chromatographic conditions include: the chromatographic column is an octadecylsilane bonded silica gel chromatographic column, the length is 75mm, and the mobile phase is methanol and The volume ratio of water is a mixed solution of 30:70, the flow rate is 0.2ml / min; the column temperature is 40°C, the quadrupole mass spectrometer detector, the atmospheric pressure chemical ionization is used as the ion source, and the selected ion (SIM) 153m / z positive For ion mode detection, the drying gas flow rate is 10L / min, the atomizing gas flow rate is 4.0L / min, the ion source voltage is 4.5KV, and the ion source temperature is 350°C.

[0028] Sample preparation:

[0029] The test solution is: take an appropriate amount of Ligustrazine hydrochloride, accurately weighed, add mobile phase to dissolve and make a solution containing about...

Embodiment 2

[0034] A method for measuring the genotoxic impurity content of ligustrazine hydrochloride, which adopts liquid chromatography-mass spectrometry, and its chromatographic conditions include: the chromatographic column is an octadecylsilane bonded silica gel chromatographic column, the length is 75mm, and the mobile phase is methanol and The volume ratio of water is a mixed solution of 20:80, the flow rate is 0.3ml / min; the column temperature is 35°C, the quadrupole mass spectrometer detector, the atmospheric pressure chemical ionization is used as the ion source, and the selected ion (SIM) 153m / z positive For ion mode detection, the drying gas flow rate is 10L / min, the atomizing gas flow rate is 4.0L / min, the ion source voltage is 4.5KV, and the ion source temperature is 350°C.

[0035] Sample preparation is the same as in Example 1.

[0036] Test operation: Take 1 μl each of the reference substance solution and the test solution and inject it into the liquid chromatograph, and...

Embodiment 3

[0038] A method for measuring the genotoxic impurity content of ligustrazine hydrochloride, which adopts liquid chromatography-mass spectrometry, and its chromatographic conditions include: the chromatographic column is an octadecylsilane bonded silica gel chromatographic column, the length is 75mm, and the mobile phase is methanol and The volume ratio of water is a mixed solution of 25:75, the flow rate is 0.5ml / min; the column temperature is 30°C, the quadrupole mass spectrometer detector, the atmospheric pressure chemical ionization is used as the ion source, and the selected ion (SIM) 153m / z positive For ion mode detection, the drying gas flow rate is 10L / min, the atomizing gas flow rate is 4.0L / min, the ion source voltage is 4.0KV, and the ion source temperature is 360°C.

[0039] Sample preparation is the same as in Example 1.

[0040] Test operation: Take 10 μl each of the reference substance solution and the test solution and inject it into the liquid chromatograph, an...

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Abstract

The invention discloses a method for determining the content of genotoxic impurities of ligustrazine hydrochloride. A liquid chromatography-mass spectrometry method is adopted. The chromatographic conditions are as follows: a chromatographic column is an octadecylsilane chemically bonded silica chromatographic column; a mobile phase is a mixed solution of methanol and water in a volume ratio of (20-40): (60-80); a flow rate is 0.2-0.6 ml / min; column temperature ranges from 25 to 45 DEG C; a quadrupole mass spectrometry detector is adopted; in atmospheric pressure chemical ionization, an ion source is adopted; a selective ion (SIM) 153 m / z positive ion mode is adopted for detection; the flow rate of dry gas is 10 L / min; the flow rate of atomized gas is 4.0 L / min; the voltage of the ion source is 4.0-5.0 KV; and the temperature of the ion source is 300-400 DEG C. With the method adopted, the content of the genotoxic impurities of the ligustrazine hydrochloride can be rapidly and accurately determined, and a foundation is laid for guaranteeing and improving the quality of the ligustrazine hydrochloride.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining the content of ligustrazine hydrochloride genotoxic impurities. Background technique [0002] Tetramethylpyrazine hydrochloride is chemically called tetramethylpyrazine hydrochloride. It has a variety of cardiovascular and cerebrovascular pharmacological effects, and is widely used in coronary heart disease, cerebral thrombosis, vasculitis and other occlusive vascular diseases. It can inhibit platelet aggregation, reduce platelet aggregation index, increase blood flow, and improve microcirculation. Ligustrazine hydrochloride can also increase the surface charge of platelets, inhibit the activation of platelets, depolymerize the aggregated platelets, and has the functions of promoting blood circulation, removing blood stasis, and antithrombosis. Cardiovascular effects: ligustrazine hydrochloride has the effects of dilating blood vessels, increasing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72
CPCG01N30/02G01N30/06G01N30/724G01N2030/047
Inventor 解启慧桑晓斌汪祥詹相
Owner HEFEI PINGGUANG PHARMA
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