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Method for determining content of piperazine ferulate

A technology of piperazine ferulic acid and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problem of not examining the separation degree of starting material vanillin and ferulic acid, the inability to ensure the separation degree of the main peak and impurities, Issues such as specificity need to be considered to achieve the effect of good repeatability and accuracy, low instrument requirements, and controllable quality

Pending Publication Date: 2021-07-02
成都亨达药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The advantage of this method is to ensure that the separation degree with cis-ferulic acid is greater than 1.5, and the specificity is better; the disadvantage is that the separation degree of the starting material vanillin and ferulic acid is not examined, and the running time is longer
[0009] In the document "Determination of the Content of Piperazine Ferulic Acid Tablets by High Performance Liquid Chromatography", water-methanol (60:40) is used as the mobile phase, isocratic elution, and the detection wavelength is 310nm. Acid, vanillin, and cis-ferulic acid were studied, but the separation between the main peak and impurities could not be ensured, and the specificity needs to be considered
[0010] In summary, there are generally problems such as poor specificity and long measurement time for the content of piperazine ferulic acid in the prior art

Method used

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  • Method for determining content of piperazine ferulate
  • Method for determining content of piperazine ferulate
  • Method for determining content of piperazine ferulate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] (1) Instrument and chromatographic conditions

[0048] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0049] Chromatographic column: Thermo Acclaim (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel column;

[0050] Configure methanol-water-acetic acid (20:80:0.1) as mobile phase A, methanol-water-acetic acid (80:20:0.1) as mobile phase B, phase A-phase B (55:45), isocratic elution , flow rate 1.0ml / min; column temperature 35°C, detection wavelength 310nm;

[0051] (2) Experimental steps

[0052] Avoid light operation.

[0053] Take the appropriate amount of piperazine ferulate reference substance, impurity A, and impurity F reference substance respectively, and use solvent [water-methanol-acetic acid (60:40:0.1)] to make each 1ml of piperazine ferulate 0.1mg, other System suitability solution containing 1 μg of each impurity;

[0054]Take an appropriate amount of sample, add diluent [methanol-water-...

Embodiment 2

[0060] (1) Instrument and chromatographic conditions

[0061] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0062] Chromatographic column: Luna C18 (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel column;

[0063] Configure 0.01M sodium acetate-methanol (80:20) as phase A, 0.01M sodium acetate-methanol (20:80) as phase B, phase A-phase B (55:45), isocratic elution, flow rate 1.0 ml / min; column temperature 35°C, detection wavelength 310nm;

[0064] (2) Experimental steps

[0065] Avoid light operation.

[0066] Take the appropriate amount of piperazine ferulate reference substance, impurity A, and impurity F reference substance respectively, and use solvent [0.01M sodium acetate-methanol (60:40)] to make each 1ml containing piperazine ferulate 0.1mg, other various System suitability solution containing 1 μg of each impurity;

[0067] Take an appropriate amount of sample, add diluent [methanol-water-acetic...

Embodiment 3

[0073] (1) Instrument and chromatographic conditions

[0074] High performance liquid chromatography: U3000 high performance liquid chromatography system and workstation;

[0075] Chromatographic column: Thermo Acclaim (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel column;

[0076] Configure methanol-water-acetic acid (20:80:0.1) as mobile phase A, methanol-water-acetic acid (80:20:0.1) as mobile phase B, phase A-phase B (55:45), isocratic elution , flow rate 1.0ml / min; column temperature 30°C, detection wavelength 310nm;

[0077] (2) Experimental steps

[0078] Avoid light operation.

[0079] Take the appropriate amount of piperazine ferulate reference substance, impurity A, and impurity F reference substance respectively, and use solvent [water-methanol-acetic acid (60:40:0.1)] to make each 1ml of piperazine ferulate 0.1mg, other System suitability solution containing 1 μg of each impurity;

[0080] Take an appropriate amount of sample, add diluent [methanol-water...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, and discloses an RT-HPLC (reverse transcription-high performance liquid chromatography) detection method for the content of piperazine ferulate, which comprises the following steps: preparing an analysis solution; using a reversed-phase chromatographic column, taking acid or acid and carboxylate aqueous solution-organic phase mixed liquid as a mobile phase, and adopting an isocratic elution method; and measuring the prepared analysis solution on a machine. The analysis method disclosed by the invention can be used for effectively and accurately determining the content of piperazine ferulate, so that the controllable quality of the product is ensured.

Description

technical field [0001] The invention belongs to chemical drug analysis methods, in particular to a method for determining the content of piperazine ferulate. Background technique [0002] Piperazine ferulate is a salt of ferulic acid combined with piperazine, its chemical name is 3-methoxy-4-hydroxypiperazine cinnamate, and its properties are white to light yellow needle-like crystals or powder. In recent years, studies have found that it has the following effects: anti-platelet aggregation, inhibiting the release of platelet 5-hydroxytryptamine, inhibiting the generation of platelet thromboxane A2 (TXA2), enhancing the activity of prostaglandins, analgesic, and relieving vasospasm. It is the basic raw material for the production of medicines for the treatment of cardiovascular and cerebrovascular diseases and leukopenia. It can also play a role in bodybuilding and skin protection in the human body. [0003] The related substances of piperazine ferulate are as follows: imp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 何亚洲王枫张倩倩左益彰周静赵卿霍立茹李战
Owner 成都亨达药业有限公司
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