Method for detecting and analyzing homopiperazine in fasudil hydrochloride injection
A technology of fasudil hydrochloride and an analysis method, which is applied in the field of detection and analysis of homopiperazine in fasudil hydrochloride injection, can solve the problems of poor stability and accuracy, inability to control the quality of fasudil hydrochloride, and inability to reflect Problems such as the real content of high piperazine
Pending Publication Date: 2021-09-28
山西省检验检测中心
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[0004] In the prior art, it has been reported in the literature that gas chromatography is used to detect the content of homopiperazine in fasudil hydrochloride, but there are problems of poor stability and accuracy, resulting in results that cannot reflect the true content of homopiperazine. Then the quality of fasudil hydrochloride cannot be controlled
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[0033] The invention provides a method for detecting and analyzing homopiperazine in fasudil hydrochloride injection, comprising the following steps:
[0034] Fasudil hydrochloride injection to be tested is diluted to obtain the test solution;
[0035] Described need testing solution is carried out ion chromatographic analysis, obtains the content of homopiperazine in the fasudil hydrochloride injection to be tested.
[0036] In the present invention, unless otherwise specified, the samples used in the present invention are all commercially available products.
[0037] In the present invention, the fasudil hydrochloride injection to be tested is diluted to obtain the test product solution on the machine.
[0038] In the present invention, the diluted reagent is preferably a 40 mmol / L methanesulfonic acid solution. The present invention does not specifically limit the consumption of the diluted reagent, and those skilled in the art can dilute the homopiperazine in the Fasudil...
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The invention belongs to the technical field of substance detection, and provides a method for detecting and analyzing homopiperazine in fasudil hydrochloride injection. The detection and analysis method comprises the following steps: diluting a fasudil hydrochloride injection to be detected to obtain a test solution; and carrying out ion chromatographic analysis on the test solution to obtain the content of homopiperazine in the fasudil hydrochloride injection to be detected. The detection and analysis method provided by the invention does not have interference peaks, and is high in stability and accuracy. Data of the embodiment show that the mass concentration of homopiperazine in the range of 1.54-9.23 mug / mL has a good linear relationship with the ion chromatographic peak area, r is equal to 0.9991, the average recovery of standard addition is 96.86%, and the relative standard deviation of the measurement result is 1.2% (3 concentrations n=9). Therefore, the detection and analysis method provided by the invention is accurate, simple, convenient and quick, and can be used for quickly determining the homopiperazine in the fasudil hydrochloride injection in actual production.
Description
technical field [0001] The invention relates to the technical field of substance detection, in particular to a detection and analysis method for homopiperazine in fasudil hydrochloride injection. Background technique [0002] Fasudil hydrochloride is an isoquinoline sulfonamide drug developed by Japan's Asahi Kasei Co., Ltd. in the 1980s. It is a protein kinase RHO inhibitor. The activity of protein hydrogen chain phosphatase can dilate blood vessels (inhibit vasospasm), reduce the tension of endothelial cells to exert the drug effect, thereby improving the microcirculation of brain tissue without generating and aggravating cerebral blood stealing. 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 regeneration. [0003] Fasudil hydrochloride, as a highly effective vasodilator, can effectively rel...
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IPC IPC(8): G01N30/02G01N30/96
CPCG01N30/02G01N30/96
Inventor 李青翠孙晋鹏史东张志英
Owner 山西省检验检测中心