Method for detecting impurities in benidipine hydrochloride bulk drug

A Beni hydrochloride, detection method technology, applied in the field of detection, to achieve the effect of high accuracy, low detection limit and high sensitivity

Pending Publication Date: 2021-04-30
山东华素制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there is no clear detection method for benidipine hydrochloride β-isomer in China and the Japanese Pharmacopoeia, so it is necessary to develop a method for its quantitative detection, and the developed method can ensure that the dehydrogenated derivative of benidipine hydrochloride ( Impurity B) and process impurities (impurity A) can also be effectively detected, and other impurities can be detected to the greatest extent

Method used

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Examples

Experimental program
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Embodiment

[0022] A method for detecting impurities in benidipine hydrochloride bulk drug, the method is to detect by liquid chromatography, comprising the following steps:

[0023] (1) Preparation of the test solution: take 25mg of this product, accurately weigh it, put it in a 50ml measuring bottle, add methanol-water (1:1) to dissolve and dilute to the mark, shake well, and use it as the test solution;

[0024] (2) Preparation of reference solution: Precisely weigh an appropriate amount of benidipine hydrochloride reference substance, add methanol-water (1:1) to dissolve and quantitatively dilute to make a solution containing about 1.0 μg of benidipine hydrochloride per 1 ml, as reference solution;

[0025] (3) Preparation of system suitability solution: take appropriate amount of impurity A reference substance, impurity B reference substance, impurity C reference substance and benidipine hydrochloride, accurately weigh, add methanol-water (1:1) to dissolve and dilute to prepare A so...

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Abstract

The invention relates to a method for detecting impurities in a benidipine hydrochloride bulk drug, provides a method for detecting impurities in benidipine hydrochloride with high detection capacity, and provides a method for detecting a beta isomer in the benidipine hydrochloride bulk drug. The technical problem that in an existing detection method, beta isomer impurities in the benidipine hydrochloride bulk drug are difficult to separate and detect is solved. According to the method for detecting the impurities in the benidipine hydrochloride bulk drug, liquid chromatography is adopted for detection, the detection limit is low, the sensitivity is high, and the accuracy is high. The method is widely applied to impurity detection in the benidipine hydrochloride bulk drug.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to a method for detecting impurities in benidipine hydrochloride bulk medicines. Background technique [0002] Benidipine hydrochloride (benidipinehydrochloride) chemical name is (±)-(R*)-1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridine The hydrochloride of methyl carboxylate [(R*)-1-benzyl-3-piperidinol ester], which belongs to dihydropyridine calcium ion antagonists, can efficiently and specifically interact with dihydropyridine receptors Combined with the binding site, it has an efficient and specific inhibitory effect on 2+2+Ca channels. Benidipine not only inhibits muscle-type (L-type) Ca channels, 2+ also inhibits voltage-dependent N-type and T-type Ca channels, and is the only calcium ion antagonist that has an effect on the above three channels agent. In addition, benidipine still has high affinity to cell membrane, vascular selectivity and renal protection, and is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 王熙红林丽丽杨淑萍宋晓娜
Owner 山东华素制药有限公司
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