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Method for detecting fasudil hydrochloride and nine related substances of fasudil hydrochloride

A technology for fasudil hydrochloride and related substances, which is applied in the fields of high performance liquid chromatography and drug analysis and detection, can solve the problems of unsatisfactory resolution, inability to accurately measure the content, etc., achieves good tailing factor, The effect of high plate count

Active Publication Date: 2019-09-10
陈海鹏
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] After searching, the Chinese patent application CN201810429938.3, the patent name is HPLC detection method for related substances of fasudil hydrochloride, provides a kind of related impurities of fasudil hydrochloride 5-isoquinolinesulfonic acid, pyridine N-oxyfasudil The method for the determination of dil, 1-hydroxyfasudil, 8-quinoline fasudil, 8-position isomer, piperazine condensate, N-hydroxyfasudil and dimer, but its There are also certain technical problems: when this method detects Fasudil hydrochloride, impurity F (i.e. the 6-position isomer), and impurity G (i.e. the 8-position isomer), the degree of separation cannot meet the requirements and cannot be accurate. Measure the content of these three substances

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  • Method for detecting fasudil hydrochloride and nine related substances of fasudil hydrochloride
  • Method for detecting fasudil hydrochloride and nine related substances of fasudil hydrochloride
  • Method for detecting fasudil hydrochloride and nine related substances of fasudil hydrochloride

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Embodiment 1

[0039] Detection Reagent

[0040] The preparation methods of reference substance stock solution, system suitability solution, impurity reference substance solution and test solution for verification are as follows:

[0041] Solvent: 20% methanol water

[0042] Reference substance stock solution: Take an appropriate amount of fasudil hydrochloride and each related substance reference substance, weigh them accurately, add methanol to dissolve and dilute to a solution with a concentration of 0.1mg / ml, and shake well to obtain.

[0043] System suitability solution: Weigh about 60 mg of Fasudil hydrochloride raw material, accurately weigh it, put it in a 100ml measuring bottle, then accurately measure the appropriate amount of each impurity stock solution, put it in the above measuring bottle, add solvent to dilute it into Fasudil hydrochloride A mixed solution with a concentration of dil of 0.6 mg / ml and a concentration of related substances of 3 μg / ml is obtained by shaking well...

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Abstract

The invention provides a method for detecting fasudil hydrochloride and nine related substances of the fasudil hydrochloride. The method comprises the following steps that a system suitability solution, a test solution and a reference solution are prepared, the solutions are injected into a high performance liquid chromatograph for detection, and the content of fasudil hydrochloride and the related substances of fasudil hydrochloride is calculated according to an external standard method; the method is characterized in that the detection conditions comprises the following conditions that a chromatographic column is an alkyl bonded silica gel packed column; a detector is a diode array detector; the detection wavelength is 240-290nm; the column temperature is 20-35 DEG C; the injection volume is 10-100[mu]l; the flow rate is 0.5-2.0ml / min; a mobile phase is buffer salt-organic phase, and pH of the buffer salt is adjusted to 3-5; and a elution method is gradient elution. The method has the following technical effects that the detection method can detect fasudil hydrochloride and nine related substances, the separation degree between fasudil hydrochloride and the related substances meets the requirements (greater than 2.0), and the number of theoretical plates is high and the tailing factor is good.

Description

technical field [0001] The invention belongs to the field of drug analysis, and relates to an analysis and detection of a drug, in particular to a high-performance liquid chromatography, which utilizes characteristic peak absorption to quantitatively detect fasudil hydrochloride and nine related substances. Background technique [0002] Fasudil hydrochloride, chemical name hexahydro-1-(5-isoquinolinesulfonyl)-1H-1,4 diazepine hydrochloride, is a RHO kinase inhibitor, which can be used to improve and prevent Cerebral vasospasm and subsequent cerebral ischemic symptoms after subarachnoid hemorrhage. [0003] In the clinical application of Fasudil hydrochloride, sometimes elevated alanine aminotransferase and aspartate aminotransferase, rash, dysuria or polyuria, vomiting, headache and other adverse reactions may occur, which may be related to the impurities. [0004] After searching, the Chinese patent application CN201810429938.3, the patent name is HPLC detection method for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/04G01N30/74G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/04G01N30/74G01N30/34G01N30/8634G01N2030/047
Inventor 常天安王蓓邹海霞陈海鹏郇恒逗
Owner 陈海鹏
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