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Method for detecting impurity F and impurity G of omeprazole sodium

A technology of omeprazole sodium and a detection method, applied in the field of pharmaceutical preparations, can solve the problems of multiple impurities, inaccurate impurities, easy changes in chemical structure and the like

Inactive Publication Date: 2021-05-18
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation process, the chemical structure of omeprazole sodium is easy to change, and a polymerization reaction occurs to generate more impurities. The current detection method for impurities is not accurate enough and has low sensitivity.

Method used

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  • Method for detecting impurity F and impurity G of omeprazole sodium
  • Method for detecting impurity F and impurity G of omeprazole sodium
  • Method for detecting impurity F and impurity G of omeprazole sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A detection method of omeprazole sodium impurity F and impurity G, comprising the steps of: adopting high performance liquid chromatography to detect omeprazole sodium impurity F and impurity G,

[0030] (1) HPLC detection conditions are as follows:

[0031] Chromatographic column: Octylsilane bonded silica gel as filler

[0032] Mobile phase A: 0.003mol / L disodium hydrogen phosphate solution-acetonitrile, adjust the pH to 7.8, the volume ratio of disodium hydrogen phosphate and acetonitrile is 73:27

[0033] Mobile Phase B: Acetonitrile

[0034] The detection wavelength is 200nm

[0035] Column temperature is 22°C

[0036] Injection volume 15μl

[0037] Flow rate 0.8ml / min

[0038] Gradient elution was carried out with mobile phase, and the elution procedure was as follows:

[0039] From 0 to 35 minutes, the volume ratio of mobile phase A to mobile phase B is 88:12;

[0040] From 35.01 to 60 minutes, the volume ratio of mobile phase A to mobile phase B is 50:50;...

Embodiment 2

[0045] A detection method of omeprazole sodium impurity F and impurity G, comprising the steps of: adopting high performance liquid chromatography to detect omeprazole sodium impurity F and impurity G,

[0046] (1) HPLC detection conditions are as follows:

[0047] Chromatographic column: Octylsilane bonded silica gel as filler

[0048] Mobile phase A: 0.012mol / L disodium hydrogen phosphate solution-acetonitrile, adjust the pH to 7.8, the volume ratio of disodium hydrogen phosphate and acetonitrile is 73:27

[0049] Mobile phase B: acetonitrile aqueous solution with a mass fraction of 0.5-1.3%

[0050] The detection wavelength is 300nm

[0051] Column temperature is 28°C

[0052] Injection volume 25μl

[0053] Flow rate 1.2ml / min

[0054] Gradient elution was carried out with mobile phase, and the elution procedure was as follows:

[0055] From 0 to 35 minutes, the volume ratio of mobile phase A to mobile phase B is 99:1;

[0056] From 35.01 to 60 minutes, the volume ra...

Embodiment 3

[0061] A detection method of omeprazole sodium impurity F and impurity G, comprising the steps of: adopting high performance liquid chromatography to detect omeprazole sodium impurity F and impurity G,

[0062] (1) HPLC detection conditions are as follows:

[0063] Chromatographic column: Octylsilane bonded silica gel as filler

[0064] Mobile phase A: 0.01mol / L disodium hydrogen phosphate solution-acetonitrile, adjust the pH to 7.8, the volume ratio of disodium hydrogen phosphate and acetonitrile is 73:27

[0065] Mobile phase B: acetonitrile aqueous solution with a mass fraction of 0.5-1.3%

[0066] The detection wavelength is 280nm

[0067] Column temperature is 25°C

[0068] Injection volume 20μl

[0069] Flow rate 1.0ml / min

[0070] Gradient elution was carried out with mobile phase, and the elution procedure was as follows:

[0071] From 0 to 35 minutes, the volume ratio of mobile phase A to mobile phase B is 90:10;

[0072] From 35.01 to 60 minutes, the volume ra...

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Abstract

The invention provides a method for detecting an impurity F and an impurity G of omeprazole sodium. The omeprazole sodium impurity F and the omeprazole sodium impurity G are detected by adopting high performance liquid chromatography, optimization is carried out on the basis of raw material medicines, and the proportion of an organic phase is increased so that the omeprazole sodium impurity F and the omeprazole sodium impurity G can be effectively eluted, and the omeprazole sodium impurity F and the omeprazole sodium impurity G can be effectively detected. Main peak retention time, an area and a height are moderate, a theoretical plate number and a separation degree are good, a tailing factor is in the range of 0.9-1.95, the S / N is 10-30, the requirements are met, and a reference basis is provided for the quality control of omeprazole sodium.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for detecting impurity F and impurity G of omeprazole sodium. Background technique [0002] Omeprazole sodium is the sodium salt of the benzimidazole compound omeprazole, the chemical name is 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridine Base)-methyl]-sulfinyl}-1H-benzimidazole sodium, its parent compound omeprazole reduces the secretion of gastric acid through the specific effect on the parietal cell proton pump, and the inhibitory effect is dose-related, and the effect is reversible. The principle is that omeprazole is a weakly alkaline substance that is concentrated and converted into an active form in the acidic environment of the parietal cells, inhibiting H + , K + -ATPase, because omeprazole sodium has a sulfuryl benzimidazole chemical structure, the stability of this structure is easily affected by factors such as the pH value of the solution, lig...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324
Inventor 刘景萍刘全国陈克领李党王家韩玉燕陈俞竹吴玉涵纪子珍吴伟贞
Owner HAINAN HULUWA PHARMA GRP CO LTD
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