Use of high efficiency liquid chromatography in measuring content of related substances in Milrinone

A technology of high performance liquid chromatography and related substances, applied in the application field of high performance liquid chromatography in the determination of the content of related substances in milrinone

Inactive Publication Date: 2005-06-01
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there is a method for measuring the content of related substances in milrinone by thin-layer chromatography, it can only control the peak area of ​​a single related substance peak (except solvent peak and lactic acid peak) to be no more than 1 / 5 of the main peak area of ​​the contrast solution, and the total Not greater than 1.5% of the main peak area of ​​the reference substance

Method used

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  • Use of high efficiency liquid chromatography in measuring content of related substances in Milrinone
  • Use of high efficiency liquid chromatography in measuring content of related substances in Milrinone
  • Use of high efficiency liquid chromatography in measuring content of related substances in Milrinone

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The establishment of embodiment 1 chromatographic conditions

[0017] Instruments: high performance liquid chromatography (Waters, USA), equipped with 515 pumps, 2487 detectors, and chemical workstations.

[0018] Reagents: milrinone and reference substance (99.7% content); methanol; chromatographically pure; water; pure water; borax; boric acid.

[0019] Column: Hypersil BDS C 18 Column (250mm×4.6mm, 5μm);

[0020] Mobile phase: 0.05mol·L -1 Borax buffer (pH=7.0):methanol:water=2:30:70;

[0021] Flow rate: 1.0ml·min -1 ;

[0022] Detection wavelength: 254nm;

[0023] Injection volume: 20 μl (quantitative tube).

[0024] The number of theoretical plates is not less than 3000 based on milrinone peak.

[0025] Linear range

[0026] Take an appropriate amount of milrinone reference substance dried at 105°C to constant weight, accurately weighed, add mobile phase to dissolve and dilute to 1ml of a solution containing 0.5mg as a standard stock solution. Precisely ...

Embodiment 2

[0041] The stability experiment of embodiment 2 high performance liquid chromatography

[0042] Compared with thin-layer chromatography, high-performance liquid chromatography has the advantages of high sensitivity and good accuracy. It can not only identify but also quantify related substances, and can better control the quality of milrinone. There are no specific reports about the specific related substances of this product in the literature, so tests such as acid, alkali, heat, and oxidative damage were designed to investigate the reliability and stability of the method system.

[0043] Interference from blank solvent

[0044] Take an appropriate amount of mobile phase, filter it, and take the filtrate for determination according to the law, and the solvent has no interference with the determination of milrinone-related substances.

[0045] acid destructive test

[0046] Take about 20 mg of milrinone, add 10 ml of 0.1 mol / L hydrochloric acid solution, heat and reflux ...

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Abstract

The present invention provides the application of high efficiency liquid phase chromatographic process in measuring the relevant matters and their content in milrinone. The flowing phase may consist of borax buffering liquid, methanol and water in the proportion of 1-5 to 20-50 to 50-80, preferably in the proportion of 1-3 to 20-40 to 60-70, and the borax buffering liquid has the preferable concentration of 0.05 M and pH value of 7.0.

Description

technical field [0001] The present invention relates to the application of high-performance liquid chromatography, more specifically, relates to the application of high-performance liquid chromatography in determining the content of related substances in milrinone. Background technique [0002] The chemical name of Milrinone is 2-methyl-6-oxo-1,6-dihydro-(3,4-bipyridine)-5-carbonitrile. Calculated on a dry basis, containing C 12 h 9 N 3 O not less than 98.5%. It is off-white or light yellow crystalline powder, odorless, almost insoluble in water or ethanol, slightly soluble in dilute hydrochloric acid. [0003] Milrinone is suitable for short-term intravenous administration in congestive heart failure. Miweinong injection can be diluted with an appropriate amount of normal saline or grape juice, and then injected slowly intravenously at 37.5μg / kg-50μg / kg for 10 minutes (injection is too fast, premature ventricular contractions may occur), and then continue to inject at ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/26G01N30/50
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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