High performance liquid phase analysis method for mildronates

A high-performance liquid phase analysis and high-performance liquid chromatography technology, which is applied in the field of medicine, can solve the problems that cannot meet the requirements of quality control, small sample load, and impurity cannot be detected.

Inactive Publication Date: 2012-07-18
ZHEJIANG JINGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] After testing, the above method cannot meet the requirements of quality control due to the small amount of sample loading and the impurity below 0.1% cannot be detected.

Method used

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  • High performance liquid phase analysis method for mildronates
  • High performance liquid phase analysis method for mildronates
  • High performance liquid phase analysis method for mildronates

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The liquid phase analysis method 1 of embodiment 1 Meldonium

[0018] Take a sample of Meldonium (hereinafter referred to as this product), add mobile phase to dissolve and make a solution containing about 20mg per 1ml for testing.

[0019] Take meldonium methyl bromide, add mobile phase to dissolve and make a solution containing about 0.2mg per 1ml for testing.

[0020] Analytical chromatographic column: mixed packing of sulfonic acid group bonding and octadecyl bonding, the mixing ratio is 1:4~20 or Shiseido CAPCELL PAK CR column (model: 1:4 or 1:20);

[0021] Detection wavelength: 200~220nm, flow rate: 0.5ml / min~1.5ml / min;

[0022] Mobile phase: 10mmol / L phosphate solution (adjust the pH value to 3.0±0.1 with phosphoric acid)-acetonitrile (75:25); take 10μl and inject it into the chromatograph for analysis.

[0023] The results showed that meldonium methyl ester, propionic acid, bromine and meldonium could all be detected on one chromatogram. And the resolution an...

Embodiment 2

[0024] The liquid phase analysis method mobile phase test of embodiment 2 Meldonium

[0025] Take this product, add mobile phase to dissolve and make a solution containing about 20mg per 1ml for testing.

[0026] Take meldonium methyl bromide, add mobile phase to dissolve and make a solution containing about 0.2mg per 1ml for testing.

[0027] Analytical chromatographic column: sulfonic acid bonded and octadecyl bonded mixed filler, the mixing ratio is 1:4~20 or Shiseido CAPCELL PAK CR column (model: 1:4 or 1:20)

[0028] Detection wavelength: 200~220nm

[0029] Flow rate: 0.5ml / min~1.5ml / min

[0030] Mobile phase: 10mmol / L phosphate solution (adjust the pH value to 3.0±0.1 with phosphoric acid)-acetonitrile (50:50)

[0031] Mobile phase: 10mmol / L phosphate solution (adjust the pH value to 3.0±0.1 with phosphoric acid)-acetonitrile (90:10)

[0032] Take 10 μl and inject it into the chromatograph for analysis.

[0033] The results showed that Meldonium methyl ester, propio...

Embodiment 3

[0036] The liquid phase analysis method 2 of embodiment 3 Meldonium

[0037] Take this product, add mobile phase to dissolve and make a solution containing about 20mg per 1ml for testing. The test solution.

[0038] Analytical chromatographic column: sulfonic acid bonded and octadecyl bonded mixed filler, the mixing ratio is 1:4~20 or Shiseido CAPCELL PAK CR column (model: 1:4 or 1:20)

[0039] Detection wavelength: 200~220nm

[0040] Flow rate: 0.5ml / min~1.5ml / min

[0041] Mobile phase: 10mmol / L perchlorate solution (adjust the pH value to 3.0±0.1 with perchloric acid)-acetonitrile (75:25)

[0042] Take 10 μl and inject it into the chromatograph for analysis.

[0043] The results showed that meldonium methyl ester, bromine and meldonium could all be detected on one chromatogram, and the resolution met the analysis requirements.

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Abstract

The invention discloses a high performance liquid phase analysis method for mildronates. The conventional analysis methods have defects that: the sample-carrying amount is small, impurities below 0.1 percent cannot be detected, and the requirements of quality control cannot be met. In the method, the mildronates are washed by a high performance liquid chromatograph, an ion exchange chromatograph method and a reversed phase chromatography method, so that all the related materials, such as mildronate methyl ester, bromine and mildronate degradation products, of the mildronates can be detected, the related materials of mildronate medicaments can be efficiently, scientifically and conveniently controlled, and an effective method is provided for the quality standard of the related materials ofthe mildronates.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a high-efficiency liquid phase analysis method for meldonium. Background technique [0002] Meldonium was first developed by the Latvian Institute of Organic Synthesis, and was marketed by Greendex Pharmaceutical Company in the 1990s. There are two dosage forms of capsules and injections. At present, the drug is widely used clinically in Russia and European Community countries, and is being developed at the same time. Japan and the United States apply for listing. The drug has not been produced or imported in my country, and there is no perfect quality standard in China. There is a high-performance liquid phase analysis method reported in the literature. All were unsatisfactory, and the sample load was small, and the detection limit could not meet the requirements. [0003] Literature method 1 (Journal of Pharmaceutical Analysis, 2006, 26(3), 358-360): adopt amino column (250mm...

Claims

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Application Information

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IPC IPC(8): G01N30/02C07C243/40
Inventor 陈鉴东任东春
Owner ZHEJIANG JINGXIN PHARMA
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