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Esomeprazole sodium or omeprazole sodium content determination method

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 the problems of difficult judgment of the end point, difficult cleaning, small jump, etc. , to achieve the effect of avoiding cleaning work, easy operation and large jump value

Active Publication Date: 2013-08-07
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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  • Esomeprazole sodium or omeprazole sodium content determination method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0024] (2) Determination of the test product: Take about 0.3g of the test product, accurately weigh it, add 50ml of ethanol-water (20%:80%) to dissolve it, and follow the potentiometric titration method (Chinese Pharmacopoeia 2010 Edition Two Appendix ⅦA) , Titrate with hydrochloric acid titrant (0.1mol / L).

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

[0026] Table 1 Ethanol-water (20%: 80%) titration data and content determination results

[0027]

[0028]

[00...

Embodiment 2

[0043] Example 2 Investigation of the detection method of the present invention

[0044] 1. Screening of ethanol-water ratio

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

[0046] 1.2 Determination of the test product: Take about 0.3g of the test product, add 50ml of ethanol-water (20-100%:0-80%) to dissolve it, and use the potentiometric titration method (Appendix ⅦA of the Second Part of Chinese Pharmacopoeia 2010 Edition). Titration with hydrochloric acid titrant (0.1mol / L).

[0047] 1.3 Test phenomena and results

[0048] 1.3.1 The potential at each point is stable, and no more 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 endpoint vol...

Embodiment 3

[0088] Example 3 Methodological investigation

[0089] 1. Repeatability test:

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

[0091] 1.2 Determination of the test product: Take 6 test samples, each about 0.3g, add 50ml ethanol-water (20%:80%) to dissolve them, and follow the potentiometric titration method (Chinese Pharmacopoeia 2010 Edition Two Appendix ⅦA), Titrate with hydrochloric acid titrant (0.1mol / L).

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

[0093] Table 13 Titration data of repeatability test using the present invention

[0094]

[0095]

[0096] Table 14 The content repeatability determination results of the present invention

[...

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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 method for determining the content of esomeprazole sodium or omeprazole sodium. Background technique [0002] Esomeprazole sodium is a specific inhibitor of proton pump in gastric parietal cells. Esomeprazole is the S-isomer of omeprazole. It is a weakly basic drug that is concentrated in the high acid environment of gastric parietal cells secreting acid microtubules and converted into an active form, thereby inhibiting H in this site. + / L + -ATPase (proton pump), inhibits both basic gastric acid secretion and gastric acid secretion after stimulation. The chemical name is S-5-methoxy-2{[﹙4-methoxy-3,5-dimethyl-2-pyridyl]methyl]sulfinyl}-1H-benzimidazole sodium; molecular formula Is: C 17 H 18 N 3 NaO 3 S; The chemical structure is as follows: [0003] [0004] Clinical studies have shown that patients with gastroesophageal reflux disease (GERD) take 30 mg and 40 mg of esomeprazole every day, and after 5 days, the average time to ...

Claims

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Application Information

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Patent Type & Authority Applications(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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