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A kind of high performance liquid chromatography separation and analysis method of olmesartan medoxomil and its intermediate

A technology of high performance liquid chromatography and olmesartan medoxomil, which is applied in the field of chemical separation and can solve problems affecting product quality and separation difficulty

Active Publication Date: 2017-07-25
JIANGSU ZHONGBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of chemical synthesis, there are several key steps of intermediates, so the intermediates may remain in the final product, which will affect the quality of the product. Therefore, it is necessary to establish a separation and analysis method for quality control. Olmesartan Medoxomil The structure of the intermediate is very similar to that of olmesartan medoxomil, so it is difficult to separate by HPLC
So far, there is no bibliographical information about the separation method of olmesartan medoxomil and its intermediates

Method used

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  • A kind of high performance liquid chromatography separation and analysis method of olmesartan medoxomil and its intermediate
  • A kind of high performance liquid chromatography separation and analysis method of olmesartan medoxomil and its intermediate
  • A kind of high performance liquid chromatography separation and analysis method of olmesartan medoxomil and its intermediate

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1) Chromatographic conditions:

[0033] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0034] Chromatographic column: C18 (150×4.6mm, 5μm);

[0035] Mobile phase: methanol, acetonitrile and a ternary mobile phase composed of disodium hydrogen phosphate-phosphate buffer with a pH value of 3.5, wherein the volume ratio of methanol: acetonitrile: disodium hydrogen phosphate-phosphate buffer with a pH value of 3.5 is =45:15:40; the disodium hydrogen phosphate-phosphate buffer solution with a pH value of 3.5 is adjusted to 3.5 by using phosphoric acid to adjust the pH value of 0.01M disodium hydrogen phosphate.

[0036] Flow rate of mobile phase: 1mL / min;

[0037] Detection wavelength: 254nm;

[0038] Column temperature: room temperature;

[0039] Injection volume: 10 μL.

[0040] 2) Preparation of sample solution: take the sample to be tested and dissolve and dilute it with the mobile phase described in the chromatographic conditions, and pr...

Embodiment 2

[0044] 1) Chromatographic conditions:

[0045] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp,

[0046] Chromatographic column: C18 (150×4.6mm, 5μm);

[0047] Mobile phase: mobile phase: ternary mobile phase composed of methanol, acetonitrile and disodium hydrogen phosphate-phosphate buffer with a pH value of 3.5, wherein methanol: acetonitrile: disodium hydrogen phosphate-phosphate buffer with a pH value of 3.5 The volume ratio is =40:20:40; the disodium hydrogen phosphate-phosphate buffer solution with a pH value of 3.5 is adjusted to 3.5 by using phosphoric acid to adjust the pH value of 0.01M disodium hydrogen phosphate.

[0048] Flow rate: 1.0mL / min;

[0049] Detection wavelength: 254nm;

[0050] Column temperature: room temperature;

[0051] Injection volume: 10 μL.

[0052] 2) Preparation of sample solution: take the sample to be tested and dissolve and dilute it with mobile phase, and prepare a sample solution containing 0.9 mg of the samp...

Embodiment 3

[0056] 1) Chromatographic conditions:

[0057] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp,

[0058] Chromatographic column: C18 (150×4.6mm, 5μm);

[0059] Mobile phase: methanol, acetonitrile and a ternary mobile phase composed of sodium acetate-acetic acid buffer with a pH value of 3, wherein the volume ratio of methanol:acetonitrile:sodium acetate-acetic acid buffer is=40:20:40; A sodium acetate-acetate buffer with a pH of 3 is prepared by adjusting the pH of 0.01M sodium acetate to 3.0 with glacial acetic acid.

[0060] Flow rate: 1.0mL / min;

[0061] Detection wavelength: 254nm;

[0062] Column temperature: room temperature;

[0063] Injection volume: 10μL

[0064] 2) Preparation of sample solution: take the sample to be tested and dissolve and dilute it with mobile phase, and prepare a sample solution containing 1.3 mg of the sample to be tested per 1 mL;

[0065] 3) Separation and analysis: Take 15 μL of the sample solution in step 2) an...

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Abstract

The present invention discloses an analysis method for the high -efficiency liquid chromatography of Omesartan and the interior body. This method uses high -efficiency liquid chromatography, with C18 as the color spectrum column, buffer (pH3.0‑6.0) and two other types of two other typesOrganic solvents form a ternary flow in a certain ratio, and the flow rate of the flow phase is 1.0ml / min. Using this method, it can quickly and effectively separate the Omesandan ester intermediate and its final products.

Description

technical field [0001] The invention relates to a chemical separation method, in particular to a high performance liquid chromatography separation and analysis method for olmesartan medoxomil and its intermediate. Background technique [0002] Olmesartan medoxomil is a new type of angiotensin II receptor blocker. It has obvious and lasting antihypertensive effect on different degrees of hypertension, and the incidence of adverse reactions is low. It is obviously superior to other ARBs in terms of overall curative effect on reducing diastolic blood pressure. In the process of chemical synthesis, there are several key steps of intermediates, so the intermediates may remain in the final product, which will affect the quality of the product. Therefore, it is necessary to establish a separation and analysis method for quality control. Olmesartan Medoxomil The structure of the intermediate is very similar to that of olmesartan medoxomil, so it is difficult to separate it by HPLC....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 薛谊王飞杨健王平韩俊芬
Owner JIANGSU ZHONGBANG PHARMA