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Torasemide genotoxic impurity detection method

A detection method, the technology of torasemide, applied in the field of chemical analysis, achieves high sensitivity, good specificity and repeatability, and accurate and reliable inspection results

Pending Publication Date: 2022-05-06
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] So far, no published method has been reported for the efficient separation and quantification of torasemide and its potential genotoxic impurities

Method used

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  • Torasemide genotoxic impurity detection method
  • Torasemide genotoxic impurity detection method
  • Torasemide genotoxic impurity detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Chromatographic conditions: use octadecylsilane bonded silica gel as a filler or a column with equivalent performance

[0071] Mobile phase A: use 0.02mol / L disodium hydrogen phosphate buffer solution, adjust the pH value to 3.5 with 2mol / L phosphoric acid)

[0072] Mobile Phase B: Acetonitrile

[0073] Column temperature 35°C

[0074] Injection volume: 10ul

[0075] Flow rate: 0.8ml / min

[0076] Detection wavelength: 210nm

[0077] Solvent: 0.04% phosphoric acid solution-acetonitrile (80:20)

[0078] Mixed reference substance solution: Accurately weigh impurity 1-7 reference substance and torasemide reference substance, add solvent to dissolve and dilute to make a mixed reference substance solution containing 0.3 μg of each impurity and 20 mg of torasemide per 1 ml .

[0079] Need testing solution: take an appropriate amount of torasemide, add a solvent to dissolve and dilute to make a solution containing 20 mg of torasemide in every 1 ml.

[0080] Gradient elut...

Embodiment 2

[0083] The detection method is:

[0084] Chromatographic conditions: use octadecylsilane bonded silica gel as a filler or a column with equivalent performance

[0085] Mobile phase A: use 0.02mol / L disodium hydrogen phosphate buffer solution, adjust the pH value to 3.5 with 2mol / L phosphoric acid)

[0086] Column temperature 35°C

[0087] Injection volume: 10ul

[0088] Flow rate: 0.8ml / min

[0089] Detection wavelength: 210nm

[0090] Solvent: 0.03% phosphoric acid solution-acetonitrile (80:20)

[0091] Mixed reference substance solution: Accurately weigh impurity 1-7 reference substance and torasemide reference substance, add solvent to dissolve and dilute to make a mixed reference substance solution containing 0.3 μg of each impurity and 20 mg of torasemide per 1 ml .

[0092] Need testing solution: take an appropriate amount of torasemide, add a solvent to dissolve and dilute to make a solution containing 20 mg of torasemide in every 1 ml.

[0093] Gradient elution ...

Embodiment 3

[0096] The detection method is:

[0097] Chromatographic conditions: use octadecylsilane bonded silica gel as a filler or a column with equivalent performance

[0098] Mobile phase A: use 0.02mol / L disodium hydrogen phosphate buffer solution, adjust the pH value to 3.5 with 2mol / L phosphoric acid)

[0099] Mobile Phase B: Acetonitrile

[0100] Column temperature 35°C

[0101] Injection volume: 10ul

[0102] Flow rate: 0.8ml / min

[0103] Detection wavelength: 210nm

[0104] Solvent: 0.05% phosphoric acid solution-acetonitrile (80:20)

[0105] Mixed reference substance solution: Accurately weigh impurity 1-7 reference substance and torasemide reference substance, add solvent to dissolve and dilute to make a mixed reference substance solution containing 0.3 μg of each impurity and 20 mg of torasemide per 1 ml .

[0106] Need testing solution: take an appropriate amount of torasemide, add a solvent to dissolve and dilute to make a solution containing 20 mg of torasemide in ...

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Abstract

According to the torasemide genotoxic impurity detection method disclosed by the invention, the genotoxic impurities in a to-be-detected sample are detected by adopting a liquid chromatography, and the to-be-detected sample is a torasemide raw material and a torasemide preparation. The genotoxic impurity is one or a combination of two of p-toluidine, 4-hydroxypyridine-3-sulfonic acid, isopropyl isocyanate, 4-chloro-3-pyridine sulfonyl chloride, m-ethylaniline, o-toluidine and m-nitrotoluene. The detection method provided by the invention is used for simultaneously separating and determining genotoxic impurities of torasemide or a preparation thereof, and is of great significance to quality control of torasemide or the preparation thereof.

Description

technical field [0001] The invention belongs to the field of chemical analysis, in particular to a method for detecting torasemide genotoxic impurities. Background technique [0002] Torsemide is a new generation of high-efficiency loop diuretics, which was launched in Germany in 1993 and in the United States in the following year. More than 20 years of clinical application have proved that torasemide has a wide range of indications, rapid, strong and long-lasting diuretic effect, low incidence of adverse reactions, and more in line with the requirements of pharmacoeconomics. It is a class of high-efficiency diuretics worth promoting in clinical practice. The chemical structural formula is as follows: [0003] [0004] Indications: It is suitable for patients with congestive heart failure, liver cirrhosis ascites, and edema caused by kidney disease who need rapid diuresis or cannot take oral diuresis. [0005] Mechanism of action: This product is a sulfonylurea pyridine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/32G01N30/54G01N30/60
CPCG01N30/02G01N30/06G01N30/34G01N30/32G01N30/54G01N30/6052G01N2030/324
Inventor 曾灿丽贺莲杨世平张静刘娟曾文洁
Owner KAMP PHARMA
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