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Method for detecting content of genotoxic impurities in pantoprazole sodium for injection

A pantoprazole sodium and detection method technology, which is applied in the field of drug analysis and detection, can solve problems such as failure to meet the detection limit, and achieve the effects of easy control, high separation, and simple operation

Active Publication Date: 2021-07-16
CHENGDU BAIYU JINGELAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Conventional gas-phase and liquid-phase detection methods cannot meet the detection limit requirements, and there are no relevant reports of these three impurities in domestic and foreign pharmacopoeias and literatures

Method used

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  • Method for detecting content of genotoxic impurities in pantoprazole sodium for injection
  • Method for detecting content of genotoxic impurities in pantoprazole sodium for injection
  • Method for detecting content of genotoxic impurities in pantoprazole sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The impurity G, impurity H and impurity I in pantoprazole sodium for injection were detected by ultra-high performance liquid chromatography-mass spectrometry.

[0059] Chromatographic column: Shim-pack VP-ODS 250×4.6mm; 5μm;

[0060] Mobile phase: 0.01mol / L ammonium acetate solution (adjust the pH to 7.0 with ammonia water)-acetonitrile (60:40 isocratic elution);

[0061] Solvent: acetonitrile: water = 1: 1;

[0062] QDA detector: Impurity G: 382Da (Negative), Impurity I: 414Da (Negative), Impurity H: 398Da (Negative)); Cone Voltage is 15Kv;

[0063] Column temperature: 40°C; flow rate: 0.7mL / min; injection volume: 10μL.

[0064] Detection steps:

[0065] Take appropriate amount of impurity G, impurity H and impurity I reference substances, dissolve them in solvent respectively, and prepare a reference substance solution containing about 1 μg of each impurity per 1 mL, to obtain impurity G reference substance solution, impurity H reference substance solution and imp...

Embodiment 2

[0145] Methodological research on detection method of the present invention

[0146] The various tests in this test example all adopt the following conditions:

[0147] Chromatographic column: Shim-pack VP-ODS 250×4.6mm; 5μm;

[0148] Mobile phase: 0.01mmol / L ammonium acetate solution (adjust the pH to 7.0 with ammonia water)-acetonitrile=60:40, isocratic elution;

[0149] Solvent: acetonitrile: water=50:50;

[0150] QDA detector: Impurity G: 382Da (Negative), Impurity I: 414Da (Negative), Impurity H: 398Da (Negative); Cone Voltage is 15Kv;

[0151] Flow rate: 0.7mL / min; injection volume: 10μL.

[0152] 1. Specific test

[0153] A. Solution preparation

[0154] Impurity mixed solution: take appropriate amount of impurity G, impurity H, and impurity I, add solvent to prepare an impurity mixed solution containing about 0.1 μg of each impurity per 1 mL.

[0155] Other impurity reference substance solution: take pantoprazole sodium impurity N, K, L, M, C, A, D, F, E, B refer...

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Abstract

The invention discloses a method for detecting the content of genotoxic impurities in pantoprazole sodium for injection. The method comprises the following steps of a, preparing a reference solution; b, preparing a test solution; c, respectively detecting the reference substance solution and the test solution by adopting an ultra-high performance liquid chromatography-mass spectrometry analysis method; and d, calculating by peak area according to an external standard method or calculating according to a standard curve between the peak area and the concentration to obtain the content of each impurity in the pantoprazole sodium sample for injection. The invention provides a novel method for detecting the content of genotoxic impurities in pantoprazole sodium for injection, chromatographic peaks are high in separation degree, free of mutual interference and high in sensitivity, impurities G, H and I can be accurately detected at the same time, The invention provides an effective detection method for monitoring the content of genotoxic impurities in pantoprazole sodium medicine for injection, and further ensures the product quality of pantoprazole sodium for injection and medication safety of patients.

Description

technical field [0001] The invention belongs to the technical field of drug analysis and detection, and in particular relates to a method for detecting the contents of impurity G, impurity H and impurity I in pantoprazole sodium for injection. Background technique [0002] Pantoprazole sodium, the chemical name is 5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole sodium (molecular formula: C 16 h 14 f 2 N 3 NaO 4 S), which is a substituted benzimidazole derivative, is an irreversible proton pump inhibitor, and is suitable for the treatment of acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and complex gastric ulcer . Commonly used are tablets, capsules and injections. [0003] Impurity G, impurity H, and impurity I are impurities degraded by light oxidation, and are impurities with nitrogen and oxygen-containing genotoxicity warning structures. According to the ICH M7 guidelines...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/7266G01N30/8675G01N2030/047
Inventor 张春暇孙泽英
Owner CHENGDU BAIYU JINGELAI PHARMA CO LTD