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Method for detecting impurities in benidipine hydrochloride tablet

A technology of benidipine hydrochloride and benidipine hydrochloride, which is applied in the field of impurity detection in benidipine hydrochloride tablets, can solve the problems of difficult product purification, high impurity content, and many by-products, and achieve high repeatability, simple operation, The effect of high accuracy

Pending Publication Date: 2021-04-30
山东华素制药有限公司
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Problems solved by technology

[0006] In the synthetic method of benidipine hydrochloride in the prior art, ubiquitous productive rate is low, and by-product is many, and product purification is difficult, and the impurity content is high in the prepared benidipine hydrochloride sheet, for the benidipine hydrochloride sheet preparation The detection of impurities and the investigation of influencing factors have a great influence

Method used

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Embodiment

[0026] A kind of impurity detection method in benidipine hydrochloride tablet, this method is to adopt liquid chromatography to detect, it is characterized in that, comprises the following steps:

[0027] (1) Preparation of the test solution: grind benidipine hydrochloride tablets to powder, take an appropriate amount of fine powder (approximately equivalent to 25 mg benidipine hydrochloride), weigh it accurately, put it in a 50ml measuring bottle, add methanol-dilute phosphoric acid Take an appropriate amount of mixed solution (the concentration of dilute phosphoric acid is 0.2%, and the volume ratio of methanol to dilute phosphoric acid is 1:1), shake it mechanically for 15 minutes, dilute to the mark with the mixed solution, shake it well, filter, and take the filtrate as the test product solution;

[0028] (2) Preparation of reference substance solution: Take an appropriate amount of benidipine hydrochloride reference substance, accurately weigh it, dissolve it with the mi...

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Abstract

The invention relates to a method for detecting impurities in a benidipine hydrochloride tablet, and solves the technical problem that no unified standard method exists in the impurity detection method in the benidipine hydrochloride tablet in China. The method for detecting impurities in the benidipine hydrochloride tablet comprises the following steps: preparing a test solution, namely respectively testing a system suitability solution prepared in step (3), a reference solution prepared in step (2) and the test solution prepared in step (1) by using high performance liquid chromatography. The method can be widely applied to the technical field of pharmacy.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a method for detecting impurities in benidipine hydrochloride tablets. Background technique [0002] Benidipine hydrochloride belongs to the class of dihydropyridine calcium ion antagonists. It binds to dihydropyridine receptors that block cell membrane potential-dependent calcium ion channels, preventing calcium ions from flowing into cells and dilating blood vessels. Benidipine hydrochloride is widely used as a therapeutic drug for hypertension, renal hypertension, angina pectoris, etc. because of its safety and effectiveness. [0003] Benidipine hydrochloride is a dihydropyridine calcium antagonist. The benidipine hydrochloride obtained through the synthesis reaction is usually a mixture of α and β diastereomers. Generally, the α and β diastereomers can be separated by recrystallization. Isomer separation. [0004] Benidipine hydrochloride is an α-isomer, which is a mixture...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06G01N30/34
CPCG01N30/06G01N30/34G01N30/88G01N2030/047G01N2030/884
Inventor 王熙红曲晓华林丽丽杨淑萍
Owner 山东华素制药有限公司
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