Detection method of relevant substances of ibuprofen injection

A technology of related substances and detection methods, applied in the field of drug-related substances, can solve the problems of injection quality and safety performance, inability to detect, etc., and achieves good chromatographic peak symmetry, quality and safety assurance, and high number of theoretical plates. Effect

Inactive Publication Date: 2019-03-26
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem solved by the present invention is the existing method for detecting related substances in ibuprofen injection. When the related substances include arginine, it is found in the process of application that the related substances of arginine in ibuprofen injection cannot be detected. Substances, but the study found that the related substances of arginine in ibuprofen injection have an important impact on the quality and safety of the injection

Method used

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  • Detection method of relevant substances of ibuprofen injection
  • Detection method of relevant substances of ibuprofen injection
  • Detection method of relevant substances of ibuprofen injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Inspection method: ChP2015 Four General Rules 0512, determination by high performance liquid chromatography.

[0043] Instrument: Agilent 1260 with ELSD detector

[0044] Chromatographic column: Kromasil 100-5-NH2, 4.6mm×250mm, 5μm or equivalent chromatographic column;

[0045] Mobile phase: acetonitrile-5mmol / L ammonium bicarbonate solution=65:35;

[0046] Injection volume: 50μl; Column temperature: 30°C; Drift tube temperature: 110°C; Carrier gas flow rate (air): 2.0L / min;

[0047] Mode: Split.

[0048]Diluent (blank solution): 65% acetonitrile solution.

[0049] Citrulline reference substance stock solution (0.2mg / ml): Accurately weigh an appropriate amount of citrulline reference substance, dissolve it in water and quantitatively dilute it with acetonitrile to make a 0.2mg / ml solution, shake well, and obtain.

[0050] Ornithine reference substance stock solution (0.2mg / ml): Accurately weigh an appropriate amount of ornithine reference substance, dissolve it in w...

Embodiment 2

[0057] Inspection method: ChP2015 Four General Rules 0512, determination by high performance liquid chromatography.

[0058] Instrument: Agilent 1260 with DAD detector.

[0059] Chromatographic column: Kromasil 100-5-NH2, 4.6mm×250mm, 5μm or equivalent chromatographic column.

[0060] Mobile phase: acetonitrile-5mmol / L ammonium bicarbonate solution=60:40.

[0061] Injection volume: 20μl; Column temperature: 30°C; Wavelength: 205nm; Flow rate: 1.3m / min.

[0062] Diluent (blank solution): 60% acetonitrile solution.

[0063] Citrulline reference substance stock solution (0.6mg / ml): Accurately weigh an appropriate amount of citrulline reference substance, dissolve it with a diluent and quantitatively dilute it to make a 0.6mg / ml solution, shake well, and obtain.

[0064] Ornithine reference substance stock solution (1mg / ml): Accurately weigh an appropriate amount of ornithine reference substance, dissolve it with a diluent and quantitatively dilute it to make a 1mg / ml solution,...

Embodiment 3

[0069] Inspection method: ChP2015 Four General Rules 0512, determination by high performance liquid chromatography.

[0070] Instrument: Agilent 1260 with DAD detector.

[0071] Chromatographic column: Kromasil 100-5-NH2, 4.6mm×250mm, 5μm or equivalent chromatographic column.

[0072] Mobile phase: acetonitrile-30mmol / L potassium dihydrogen phosphate solution (pH5.4)=60:40.

[0073] Injection volume: 20μl; Column temperature: 30°C; Wavelength: 205nm; Flow rate: 1.3m / min.

[0074] Diluent (blank solution): 60% acetonitrile solution. Citrulline reference substance stock solution (0.6mg / ml): Accurately weigh an appropriate amount of citrulline reference substance, dissolve it with a diluent and quantitatively dilute it to make a 0.6mg / ml solution, shake well, and obtain.

[0075] Ornithine reference substance stock solution (1mg / ml): Accurately weigh an appropriate amount of ornithine reference substance, dissolve it with a diluent and quantitatively dilute it to make a 1mg / ml...

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Abstract

The invention discloses a detection method of relevant substances of ibuprofen injection. The relevant substances comprise arginine. A high performance liquid chromatography method is used for detection; the relevant substances are subjected to qualitative or quantitative detection. The detection conditions comprise a detector being an ELSD detector, a chromatographic column being an alkyl silanebonded silica gel column or an amino column, flowing phases including an organic phase and a water phase at the volume ratio of (50 to 70):(50 to 30) (preferably 65:35). By using the method provided by the invention, the relevant substance of the arginine can be accurately monitored; the guarantee is provided for the quality and safety of the ibuprofen injection.

Description

technical field [0001] The invention relates to the field of drug-related substances, in particular to a method for detecting related substances of ibuprofen injection. Background technique [0002] Ibuprofen injection is produced by Cumberland Pharmaceuticals in the United States. It was approved by the FDA in June 2009. Its product name is "CALDOLOR", and it has not entered the Chinese market. People with pain and people with fever. At present, South Korea is in the state of registration, and Australia and Canada are in the state of pre-registration. The prescription is protected by a patent, and the injection is composed of ibuprofen and arginine with a molar ratio of 1:0.92. There are two listed specifications (1) 4ml: 400mg (2) 8ml: 800mg. The usage and dosage in the instructions are intravenous infusion. The dosage should not exceed 3200mg / day. The drug must be diluted before intravenous infusion. Dilute to a final concentration of not more than 4mg / ml. 1. Analg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 丁凤周润梅童庆国罗鸣黄浩喜李英富苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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