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

A technology of glipizide and detection method, which is applied in the detection field of simultaneous determination of the content of 8 compounds in glipizide drugs, can solve the problem that the lower limit of the linear range of the compound and the high limit of quantification of detection cannot effectively prove the accuracy of impurities , reliability and reproducibility, uncertainty of quantitative determination, etc.

Active Publication Date: 2021-03-30
山东则正医药技术有限公司
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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 effect

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

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Embodiment Construction

[0091] The present invention will be further described below in conjunction with specific embodiments, so that those skilled in the art can better understand the present invention, but the present invention is not limited thereby. Details are as follows:

[0092] 1. Chromatographic conditions

[0093] Column: EclipseXDB-C 18 (150mm*4.6mm, 5μm); mobile phase A: 0.05M potassium dihydrogen phosphate solution (phosphoric acid to adjust the pH to 3.5); mobile phase B: acetonitrile; flow rate: 1.0mL min -1 ; Detection wavelength: 225nm; Column temperature: 35° C.; Injection volume: 20 μL; Gradient program (see Table 1).

[0094] Table 1 Elution program

[0095]

[0096] 2. Solution preparation

[0097] Diluent: Methanol: Acetonitrile: Water = 3:8:14

[0098] Compound Ⅰ reference substance stock solution: Accurately weigh 4.700 mg of compound Ⅰ reference substance, put it in a 50ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, and refrigerate a...

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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...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 代秀梅贺敦伟
Owner 山东则正医药技术有限公司
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