Detection method for simultaneously determining content of eight compounds in glipizide drugs

Abstract

The invention belongs to the technical field of detection, and particularly relates to a detection method for simultaneously determining the content of eight compounds in glipizide drugs. The determination method is a reversed-phase high performance liquid chromatography method. The method can be used for simultaneously determining eight compounds in glipizide synthetic intermediates, glipizide bulk drugs and glipizide-containing drugs.

Description

technical field [0001] The invention belongs to the technical field of detection, and in particular relates to a detection method for simultaneously measuring the contents of eight compounds in glipizides. This method can be used for the simultaneous determination of 8 compounds in glipizide synthesis intermediates, glipizide raw materials, and glipizide-containing drugs. Background technique [0002] Glipizide is a hypoglycemic drug widely used clinically. The drug is a chemically synthesized drug, and there are inevitably other impurities, which mainly come from three aspects. On the one hand, it is the compound produced by the side reaction that occurs during the synthesis process; on the other hand, it is the starting compound and intermediate product residue of the synthesis; on the other hand, it is the impurity produced during the storage and transportation of the raw material drug or pharmaceutical preparation. 4-[2-(5-methylpyrazine-2-formylamino)ethyl]benzenesulf...

AI Technical Summary

Problems solved by technology

[0037] This method has the following deficiencies: (1) The method claims that "the method can be used to realize the qualitative and quantitative detection of glipizide and impurities A-L", but Comparative Document 1 only gives 11 The determination chromatographic condition of impurity, its embodiment and chromatogram have only provided the resolution experiment chromatogram peak retention time and chromatogram of adding impurity reference substance, only be equivalent to " specificity test " in the method test, only give The specific experimental spectrum cannot effectively prove the accuracy, reliability and reproducibility of this method for the quantitative determination of impurities in glipizide

(2) This method has not further clarified whether it is determined by the external standard method, the standard curve method, or its own principal component control method, so it cannot be determined that it can accurately quantify the impurities in glipizide

(3) The lower limit of the linear range of the compound and the quantitative limit of detection in this method are all high, which is not suitable for the detection of trace impurities

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