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The assay method of esomeprazole sodium or omeprazole sodium

A technology of esomeprazole sodium and omeprazole sodium, which is applied in the field of content determination of esomeprazole sodium or omeprazole sodium, and can solve problems such as difficult cleaning, small jumps, and difficult judgment of the end point , to achieve the effect of avoiding cleaning work, large jump value and easy operation

Active Publication Date: 2015-12-02
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned standard method has a small jump in the titration process, and the end point is difficult to judge, and the generated product adheres to the container and the electrode, which is extremely difficult to clean

Method used

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  • The assay method of esomeprazole sodium or omeprazole sodium
  • The assay method of esomeprazole sodium or omeprazole sodium
  • The assay method of esomeprazole sodium or omeprazole sodium

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The detection method of embodiment 1 esomeprazole sodium of the present invention

[0023] (1) Blank test: Take 50ml of ethanol-water (20%︰80%), titrate with hydrochloric acid titration solution (0.1mol / L) according to the potentiometric titration method (Appendix VIIA of Part Two of the Chinese Pharmacopoeia 2010 Edition).

[0024] (2) Determination of the test product: Take about 0.3 g of the test product, weigh it accurately, add 50 ml of ethanol-water (20%︰80%) to dissolve it, and use the potentiometric titration method (Appendix VIIA of the second part of the Chinese Pharmacopoeia 2010 edition) , Titrate with hydrochloric acid titration solution (0.1mol / L).

[0025] (3) The titration data is processed by the second-order reciprocal method, and the end point volume is calculated. Titration data and content determination results are shown in Table 1, and the second-order reciprocal graph is shown in figure 1 .

[0026] Table 1 Ethanol-water (20%: 80%) titration da...

Embodiment 2

[0043] The investigation of embodiment 2 detection method of the present invention

[0044] 1. Ethanol-water ratio screening

[0045] 1.1 Blank test: Take 50ml of ethanol-water (20-100%︰0-80%), and titrate with hydrochloric acid titration solution (0.1mol / L) according to the potentiometric titration method (Appendix VIIA of Part Two of the Chinese Pharmacopoeia 2010 Edition).

[0046] 1.2 Determination of the test sample: take about 0.3g of the test sample, add 50ml of ethanol-water (20-100%︰0-80%) to dissolve it, and use Titrate with hydrochloric acid titrant (0.1mol / L).

[0047] 1.3 Experimental phenomena and results

[0048] 1.3.1 The potential of each point is stable, and no precipitation and viscous substances are formed.

[0049] 1.3.2 The titration data and content determination results are shown in Table 3-7 (the titration data is processed by the second-order reciprocal method, and the end point volume is calculated).

[0050] Table 3 Ethanol-water (100%: 0%) titr...

Embodiment 3

[0088] Embodiment 3 methodological investigation

[0089] 1. Repeatability test:

[0090] 1.1 Blank test: Take 50ml of ethanol-water (20%︰80%), titrate with hydrochloric acid titration solution (0.1mol / L) according to the potentiometric titration method (Appendix VIIA of Part Two of the Chinese Pharmacopoeia 2010 Edition).

[0091] 1.2 Determination of the test product: Take 6 parts of the test product, each about 0.3g, add 50ml of ethanol-water (20%︰80%) to dissolve, and use the potentiometric titration method (Appendix VIIA of the second part of the Chinese Pharmacopoeia 2010 edition), Titrate with hydrochloric acid titration solution (0.1mol / L).

[0092] 1.3 The titration data is processed by the second-order reciprocal method, and the end point volume is calculated. The titration data is shown in Table 13, and the content inspection results are shown in Table 14.

[0093] Table 13 adopts the present invention to carry out repeatability test titration data

[0094]

...

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Abstract

The invention provides an esomeprazole sodium or omeprazole sodium content determination method. The method comprises the operation steps that: a sample requiring determination is fetched; precise weighing is carried out; an alcohol-water solution is added, such that the sample is dissolved; with a potentiometric titration method, titration is carried out by using a sulfuric acid titration solution or a hydrochloric acid titration solution, such that the content of esomeprazole sodium or omeprazole sodium is obtained. Each 1mmol of H<+> is equivalent to 36.74mg of C17H18N3NaO3S. An alcohol-water volume ratio is (20-100%):(80-0%). The alcohol is ethanol or methanol. The mass volume ratio of the sample and the alcohol-water solution is 2-10mg / ml. The detection method provided by the invention has large sudden-change value, such that the method is beneficial for titration terminal determination, and the determination of the content of esomeprazole sodium or omeprazole sodium is more accurate. Also, with the method provided by the invention, precipitation is prevented, such that subsequent cleaning work is prevented, and operation is more convenient.

Description

technical field [0001] The invention relates to a content determination method of esomeprazole sodium or omeprazole sodium. Background technique [0002] Esomeprazole sodium is a specific inhibitor of the proton pump in gastric parietal cells. Esomeprazole, the S-isomer of omeprazole, is a weakly basic drug that concentrates and converts into an active form in the high-acid environment of the acid-oxyntic microtubules of parietal cells, thereby inhibiting the H + / L + -ATPase (proton pump), inhibits both basal and stimulated gastric acid secretion. The chemical name is S-5-methoxy-2{[[4-methoxy-3,5-dimethyl-2-pyridyl]methyl]sulfinyl}-1H-sodium benzimidazole; molecular formula For: C 17 h 18 N 3 NaO 3 S; the chemical structural formula is as follows: [0003] [0004] Clinical studies have shown that patients with gastroesophageal reflux disease (GERD) take 30mg and 40mg of esomeprazole orally every day, and after 5 days, the average time to maintain pH>4 in the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N1/28
Inventor 孙毅田阿娟陈明霞
Owner CHENGDU BAIYU PHARMA CO LTD
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