Detection method for sodium impurities in omeprazole

An inspection method and impurity technology, which is applied in the field of omeprazole sodium impurity inspection, can solve problems such as long equilibration time, large damage to the chromatographic column, and impurity damage, and achieve the effect of long equilibration time

Active Publication Date: 2012-10-17
SHANDONG HEXING PHARMA
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Problems solved by technology

[0003] The present invention proposes an impurity inspection method for omeprazole sodium, which solves the problem that the impurity cannot be destroyed in the prior art, and the composition of the impurity can be accurately analyzed. The chromatographic column is damaged a lot and the cost is high

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  • Detection method for sodium impurities in omeprazole

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Embodiment Construction

[0014] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

[0015] As shown in the accompanying drawing, a kind of omeprazole sodium impurity testing method comprises steps:

[0016] 1) High-performance liquid chromatography is adopted, and the chromatographic conditions are as follows: use octadecylsilane bonded silica gel as a filler; use phosphate buffer, tetrabutylamine hydrogen sulfate buffer, and acetonitrile in a volume ratio of 64:6:30 as Mobile phase, the detection wavelength is 280nm;

[0017] 2) preparation of s...

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Abstract

The present invention provides a detection method for sodium impurities in omeprazole. The method comprises the following steps: 1) adopting a high performance liquid chromatography, wherein chromatographic conditions comprise that: octadecylsilane chemically bonded silica gel is adopted as a filler, a phosphate buffer, a tetrabutylammonium hydrogen sulfate buffer and acetonitrile are mixed according to a volume ratio of 64:6:30 to be adopted as a mobile phase, and a detection wavelength is 280 nm; 2) preparing a system suitability test solution, wherein 10 ml of omeprazole is placed in a 50 ml volumetric flask, 5 ml of a mixing solution is added to the 50 ml volumetric flask, a shaking treatment is performed to dissolve, and the solution inside the 50 ml volumetric flask is diluted into 50 ml to obtain a mixed solution of omeprazole and an omeprazole sulfonylation compound, wherein the mixing solution is prepared by mixing a potassium permanganate solution with a mass content of 0.05% and acetonitrile according to a volume ratio of 1:1, and the resulting mixed solution is adopted as the system suitability test solution; and 3) measuring, wherein 10-20 mul of the system suitability test solution is taken and injected into the chromatograph, and the chromatogram is recorded. With the present invention, the impurities are effectively destroyed, the analysis is accurate, the system stability is good, the balance time is short, and the coat is low.

Description

technical field [0001] The invention relates to the technical field of medicament detection, in particular to an impurity detection method for omeprazole sodium. Background technique [0002] The original technology cannot destroy the impurities and accurately analyze the components of the impurities. The impurities are difficult to separate, and the stability of the chromatographic inspection system is poor. At the same time, the traditional method requires a long equilibration time, and the damage to the traditional chromatographic column is great, and the cost is high. . Contents of the invention [0003] The present invention proposes an impurity inspection method for omeprazole sodium, which solves the problem that the impurity cannot be destroyed in the prior art, and the composition of the impurity can be accurately analyzed. The chromatographic column is very damaged and the cost is high. [0004] The technical scheme of the present invention is achieved in that ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王素琴
Owner SHANDONG HEXING PHARMA
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