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Method for detecting homopiperazine in fasudil hydrochloride

A technology of fasudil hydrochloride and homopiperazine, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not being able to reflect the true content of homopiperazine, and achieve good accuracy, high detection sensitivity, and wide linear range Effect

Active Publication Date: 2019-04-02
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem mainly solved by the present invention is that the method for detecting homopiperazine from fasudil hydrochloride in the prior art cannot reflect the true content of homopiperazine in fasudil hydrochloride due to various problems

Method used

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  • Method for detecting homopiperazine in fasudil hydrochloride
  • Method for detecting homopiperazine in fasudil hydrochloride
  • Method for detecting homopiperazine in fasudil hydrochloride

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 1. Setting limits

[0061] The limit of homopiperazine in fasudil hydrochloride should not exceed 0.1%.

[0062] 2. Establishment of analytical methods

[0063] Table 1 is a screening summary of the analytical method for detecting homopiperazine in fasudil hydrochloride:

[0064] Table 1 Summary of the screening method for the detection of homopiperazine in fasudil hydrochloride

[0065]

[0066]

[0067] 2.1 Method using ammonia water and methanol as diluent

[0068] Using ammonia and methanol as the diluent, the chromatographic conditions are shown in Table 2. Under these conditions, the specificity, sensitivity and accuracy of homopiperazine were investigated.

[0069] Analysis method for detecting homopiperazine in table 2 fasudil hydrochloride

[0070]

[0071] Conclusion: if figure 1 Shown, blank solution, need testing solution and standard-added need testing solution all do not interfere with the detection of homopiperazine; Homopiperazine sensitivi...

Embodiment 2

[0103] Take an appropriate amount of Fasudil hydrochloride, accurately weigh it, and dissolve it with a diluent (methanol: 1,8-diazabicycloundec-7-ene (abbreviation: DBU) = 10:0.2 (V:V)) And quantitatively diluted to a solution containing about 30 mg of the test product in every 1 ml, as the solution of the test product; another appropriate amount of homopiperazine was taken, accurately weighed, dissolved with a diluent and quantitatively diluted to contain about 0.03 mg of homopiperazine in every 1 ml mg solution, as the reference solution; another diluent (methanol: 1,8-diazabicycloundec-7-ene (abbreviation: DBU) = 10:0.2 (V:V)) as a blank solution In addition, take each appropriate amount of Fasudil hydrochloride and Homopiperazine, accurately weighed, dissolve with diluent and quantitatively dilute into a solution that contains about 30 mg of test sample and 0.03 mg of Homopiperazine in every 1 ml, as the test sample for adding standards solution. Measure according to res...

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Abstract

The invention discloses a method for detecting homopiperazine in fasudil hydrochloride, which uses gas chromatography to qualitatively or quantitatively detect the homopiperazine in the fasudil hydrochloride. The diluent used in the sampling detection solution in the gas chromatography comprises DBU and organic solvent. According to the method for detecting the homopiperazine in the fasudil hydrochloride, the homopiperazine in the fasudil hydrochloride can be detected effectively and veritably, and the quality and the safety of fasudil hydrochloride are guaranteed.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting homopiperazine from fasudil hydrochloride. Background technique [0002] Fasudil hydrochloride is an isoquinoline sulfonamide drug developed by Japan's Asahi Kasei (Asahi Kasei) Co., Ltd. in the 1980s. It is a protein kinase RHO inhibitor (intracellular calcium ion antagonist) that blocks vasoconstriction. The final stage of the process, that is, by increasing the activity of myosin hydrogen chain phosphatase, dilating blood vessels (inhibiting vasospasm), reducing the tension of endothelial cells to exert the drug effect, thereby improving the microcirculation of brain tissue, without generating and aggravating brain piracy Blood. Clinically, it is mainly used to improve and prevent cerebral spasm after subarachnoid hemorrhage and the symptoms of cerebral ischemia caused by it. At the same time, it can also protect nerves against apoptosis and promote nerve ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 吕清慧陈礼莉文信琼苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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