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Method for simultaneously detecting clevidipine butyrate and related substances

A technology for clevidipine butyrate and related substances, which is applied in the field of raw drug detection of clevidipine butyrate, can solve the problems of not giving three kinds of impurity names, analysis of other related substances, etc., and achieves good reproducibility and precision high effect

Inactive Publication Date: 2015-11-25
SHANGHAI XINPING MEDICALSCI&TECH CO LTD
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  • Description
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  • Application Information

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Problems solved by technology

People such as Yuan Huiya briefly explored clevidipine butyrate and an intermediate thereof, but did not analyze other related substances; the invention patent of patent No. CN10313489A discloses a method of using high-performance liquid Determination methods for vedipine and three impurities, but did not give the specific names of the three impurities

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  • Method for simultaneously detecting clevidipine butyrate and related substances
  • Method for simultaneously detecting clevidipine butyrate and related substances
  • Method for simultaneously detecting clevidipine butyrate and related substances

Examples

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Embodiment 1

[0064] The optimization of embodiment one high performance liquid chromatography conditions

[0065] In this embodiment, by analyzing the mixed reference substance solution, the optimal high performance liquid chromatography conditions are determined, and the optimal chromatographic conditions are explored from the aspects of detection wavelength, chromatographic column, mobile phase, flow rate and column temperature.

[0066] In this example, the standard for achieving effective separation of clevidipine butyrate and its 11 impurities is: separation between each chromatographic peak≥resolution.

[0067] (1) Investigation of ultraviolet wavelength

[0068] It can be known from the ultraviolet absorption characteristics of each substance that impurities ⑤, ⑧, and ⑨ only absorb at the end. Considering the stability of the baseline, 220nm is selected as the detection wavelength. The main components and other impurities also have good absorption at this detection wavelength.

...

Embodiment 2

[0083] Embodiment two, mixed reference substance solution, clevidipine butyrate contrast solution and need testing solution test

[0084] The present embodiment adopts the chromatographic conditions in embodiment one to carry out the test of mixed reference substance solution, clevidipine butyrate contrast solution and need testing solution.

[0085] (1), detection of mixed reference substance solution and clevidipine butyrate reference solution

[0086] According to the method of solvent configuration in 3, configure mixed reference substance solution and clevidipine butyrate contrast solution respectively, accurately draw 20 μ L of each of the two solutions, inject into the high performance liquid chromatograph supplemented by photodiode array detector, and then follow the embodiment One of the preferred chromatographic conditions for detection.

[0087] figure 2 (a) is the chromatogram of the mixed reference substance in the present embodiment.

[0088] figure 2 (b) i...

Embodiment 3

[0103] Embodiment three method verification

[0104] This embodiment carries out methodological verification to the preferred chromatographic conditions in embodiment one, mainly in the following five aspects:

[0105] (1), linear range, detection limit and quantification limit

[0106] Weigh the appropriate amount of 11 kinds of impurities and clevidipine butyrate reference substance respectively, and prepare a series of concentration solutions corresponding to 50%, 80%, 100%, 120% and 150% under the conditions of content determination, and measure and investigate the linearity of each component. relationship and relative correction factor. Take the injection concentration (mg / L) as the abscissa, and the peak area as the ordinate, perform regression curve analysis, and calculate the quantitative limit of the method with 10 times the signal-to-noise ratio (S / N=10), and use 3 times the signal-to-noise ratio (S / N=3) the detection limit of calculation method, the results are ...

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Abstract

The invention provides a method for simultaneously detecting clevidipine butyrate and eleven related substances and a method for determining clevidipine butyrate content. The methods utilize a reversed phase high-performance liquid chromatography method. Through a lot of repeated experiments, chromatographic conditions for simultaneously separating clevidipine butyrate and eleven related substances and conditions for determining clevidipine butyrate content are acquired, and the chromatographic conditions are suitable for analysis of clevidipine butyrate drug ingredients and content in different environments so that the problem that in analysis of clevidipine butyrate drug ingredients in different environments, the prior art needs respective exploration of corresponding chromatographic conditions. The chromatographic conditions have the advantages of high precision, good reappearance, good durability and mastering easiness.

Description

technical field [0001] The invention belongs to the field of detection of clevidipine butyrate crude drug, in particular to a method for simultaneously determining clevidipine butyrate and eleven related substances. Background technique [0002] Clevidipine butyrate (Clevidipinebutyrate, CLE), its chemical name is 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid Methyl (1-butyryloxy) methyl ester, its structural formula is: [0003] [0004] Clevidipine butyrate is a new type of antihypertensive drug for intravenous injection developed by AstraZeneca Company of the United Kingdom. It was approved by the US FDA in August 2008 and is mainly used for the treatment of acute hypertension and the control of postoperative blood pressure. Clevidipine butyrate is an ultra-short-acting dihydropyridine calcium channel antagonist, which can selectively inhibit the extracellular calcium influx in arterial vascular smooth muscle cells. It has a rapid onset...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 刘艳华张倩倩宋志勇李旭萍
Owner SHANGHAI XINPING MEDICALSCI&TECH CO LTD
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