System suitability testing method of chromatographic detection method for sodium impurities in omeprazole

Abstract

The present invention provides a system suitability detection method used for chromatographic detection method of 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 a system suitability testing method for a chromatographic detection method of omeprazole sodium impurities. 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 impurity is difficult to separate, the stability of the chromatographic inspection...

AI Technical Summary

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, the composition of the impurity can be accurately analyzed, the impurity is difficult to separate, the stability of the chromatographic inspection system is poor, and the equilibration time is long. The chromatographic column is damaged a lot and the cost is high

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