Method for separating and analyzing milrinone

A technology of separation analysis and milrinone, which is applied in the field of analytical chemistry, can solve the problems of unstable baseline, low theoretical plate number, and small number of impurities, etc., and achieve the effect of stable baseline, high theoretical plate number and quality control

Active Publication Date: 2015-03-18
NEW FOUNDER HLDG DEV LLC +2
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Problems solved by technology

However, when detected by this method, it was found that the number of theoretical plates of milrinone was low, the baseline was not stable, and th

Method used

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  • Method for separating and analyzing milrinone
  • Method for separating and analyzing milrinone
  • Method for separating and analyzing milrinone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0217] Sample Preparation:

[0218] Take 2.7 g of potassium dihydrogen phosphate, add 1000 ml of water to dissolve it, add 3.0 ml of triethylamine to it, adjust the pH value to 6.0 with 10% phosphoric acid solution, and obtain the aqueous phase. The aqueous phase and methanol were prepared as the mobile phase at a volume ratio of 80:20.

[0219] Accurately weigh about 10 mg of milrinone, add an appropriate amount of methanol, and ultrasonicate for 1 minute at room temperature. After the milrinone is completely dissolved, dilute it with the mobile phase to form a solution with a concentration of 1 mg / ml of milrinone as the test solution. .

[0220] Accurately measure the test solution, and dilute it with the mobile phase to a solution with a concentration of milrinone of 1 μg / ml, as a contrast solution.

[0221] Accurately weigh an appropriate amount of milrinone-related substance A reference substance, mix it with an appropriate amount of methanol-water (volume ratio of 80:2...

Embodiment 2

[0233] Sample preparation, chromatographic conditions and determination methods were all carried out according to the method of Example 1, except that the pH of the mobile phase was 5.8.

[0234] The results of testing the test solution are as follows: Figure 23 As shown in the figure, it can be seen that under the conditions of the present invention, the main peak of milrinone can be effectively separated from each impurity, the chromatographic peak shape of milrinone is better, and the baseline is relatively stable, and the related substances in milrinone can be accurately measured .

Embodiment 3

[0236] Sample preparation, chromatographic conditions and determination methods were all carried out according to the method of Example 1, except that the pH of the mobile phase was 6.2.

[0237] The results of testing the test solution are as follows: Figure 24 As shown in the figure, it can be seen that under the conditions of the present invention, the main peak of milrinone can be effectively separated from each impurity, the chromatographic peak shape of milrinone is better, and the baseline is relatively stable, and the related substances in milrinone can be accurately measured .

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Abstract

The invention relates to a method for separating and analyzing milrinone. According to the method, a milrinone sample is detected by adopting a high performance liquid chromatography, wherein the high performance liquid chromatography takes a methanol-phosphate solution as a mobile phase, the phosphate solution contains diethylamine or triethylamine, and the pH of the phosphate solution is 5.5-6.5. According to the method provided by the invention, the milrinone can be effectively separated from a synthesized intermediate body-1-(4-pyridyl)acetone and other related substances; the number of theoretical plates of a chromatographic peak is high and a base line is stable; and a relatively large quantity of impurities can be detected so that the sensitivity and the accuracy for detecting the milrinone and the related substances of the milrinone are greatly improved. The method provided by the invention lays a foundation for the quality control of the milrinone and related preparations of the milrinone.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and analyzing milrinone. Background technique [0002] The molecular formula of Milrinone is C 12 h 9 N 3 O, the molecular weight is 211.22, the chemical name is 1,6-dihydro-2-methyl-6-oxo-[3,4'-dipyridine]-5-carbonitrile, and its chemical structural formula is as follows: [0003] [0004] Milrinone and Milrinone Injection are anti-heart failure drugs, belonging to phosphodiesterase inhibitors among new positive inotropic drugs, which are used to treat acute and chronic intractable congestive heart failure caused by various reasons. failure, and the disease is ineffective or poorly treated with digitalis, diuretics, and vasodilators. Milrinone and its injections have been produced and marketed in China, and there are also imported preparations. The domestically produced and marketed drug is Milrinone Injection produced by Shandong L...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 易崇勤兰静郑少辉郭欲晓
Owner NEW FOUNDER HLDG DEV LLC
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