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Method for measuring content uniformity of benidipine hydrochloride tablet

A technology for the determination of benidipine hydrochloride and its method is applied in the field of determination of the content uniformity of benidipine hydrochloride tablets, which can solve the problems of falsely high results and achieve the effects of simple operation, reliable method and high repeatability

Pending Publication Date: 2021-04-30
山东华素制药有限公司
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AI Technical Summary

Problems solved by technology

The chromatographic peak of the β isomer is adjacent to the active ingredient, and improper selection of chromatographic conditions will cause the isomer to merge with the main component, resulting in falsely high results

Method used

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Examples

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Embodiment

[0021] A method for assaying content uniformity of benidipine hydrochloride tablets, comprising the following steps:

[0022] Get 1 tablet of benidipine hydrochloride, put it in a 100ml measuring bottle, add an appropriate amount of methanol-dilute phosphoric acid mixed solution, ultrasonically dissolve benidipine hydrochloride and dilute to the scale, shake well, filter, and take the subsequent filtrate as the test solution .

[0023] The concentration of dilute phosphoric acid is 0.2%, and the volume ratio of methanol-dilute phosphoric acid is 1:1.

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PUM

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Abstract

The invention relates to a method for measuring the content uniformity of a benidipine hydrochloride tablet, and solves the technical problems of poor discrimination, complex operation, long detection time and great influence on the health of personnel in the existing method for determining the content uniformity of the benidipine hydrochloride tablet. The method for measuring the content uniformity of the benidipine hydrochloride tablet comprises the following steps: taking one benidipine hydrochloride tablet, putting the benidipine hydrochloride tablet into a 100ml measuring flask, adding a proper amount of methanol-dilute phosphoric acid mixed solution, ultrasonically dissolving and diluting benidipine hydrochloride to a scale, uniformly shaking, filtering, and taking the subsequent filtrate as a test solution. The method is widely applied to detection of the content uniformity of the benidipine hydrochloride tablets.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a method for measuring the content uniformity of 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] Content uniformity is a key parameter for evaluating the quality of pharmaceuticals, and it is also a key factor for testing the quality of pharmaceuticals stipulated in the "Chinese Pharmacopoeia". The content is guaranteed for the whole batch of products, and the content uniformity depends on the difference between the content of ...

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 王熙红林丽丽杨淑萍陈莉
Owner 山东华素制药有限公司
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