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Method for determining dexibuprofen related matter

A technology for related substances and impurities, which is applied in the field of determination of dextroibuprofen related substances, can solve the problems of no literature report and few related substances analysis methods, and achieves the effects of good durability and high precision

Inactive Publication Date: 2017-05-10
NANJING CORE TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the dosage form of dexibuprofen that has been marketed abroad is a tablet. However, due to data protection and other reasons, there is no literature report on the related substance analysis method of this raw material drug.
And domestic marketed dextrobuprofen dosage form is capsule, only one impurity has been controlled in its quality standard; And the impurity that has been reported in the current ibuprofen crude drug has 18 kinds, but these impurities are separated and measured simultaneously There are not many documents

Method used

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  • Method for determining dexibuprofen related matter
  • Method for determining dexibuprofen related matter
  • Method for determining dexibuprofen related matter

Examples

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Embodiment 1

[0014] The reversed-phase high-performance liquid chromatography of embodiment 1 Dexibuprofen related substances is determined

[0015] Chromatographic conditions and system adaptability: Octadecylsilane bonded silica gel is used as filler (SHISEIDO CAPCELLC18 MGⅡ 3μm 4.6×150mm), detection wavelength is 214nm, column temperature is 25°C, and flow rate is 1.0mL / min. Mobile phase A is: 0.5ml phosphoric acid plus 340ml acetonitrile plus 600ml water to a 1000ml measuring bottle, mix well, add water to dilute to the mark, phase B: acetonitrile, the gradient program is shown in the table below. Gradient elution was carried out according to the following mobile phase conditions:

[0016] time (min) mobile phase A mobile phase B 0 80 20 25 80 20 25.1 5 95 45 5 95 45.1 80 20 55 80 20

[0017] The following items related to the detection method of the substance have been verified:

[0018] 1. System suitability experiment

[0019] ...

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Abstract

The invention discloses a method for determining a dexibuprofen related matter. According to the method, a high performance liquid chromatography method is adopted for simultaneously determining and checking 17 related impurities, such as, impurity A, impurity B, impurity C, and the like, possible to appear in dexibuprofen bulk drug. The method is time-saving, labor-saving and high in precision. Through verification, the method can be used for conventional analysis and quality control for the dexibuprofen raw material and the preparation sample.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a quality control method of a dextroibuprofen crude drug, in particular to a method for determining related substances of dextrobuprofen. Background technique [0002] Dexibuprofen, English name Dexibuprofen, chemical name S-(+)-2-(4-isobutylphenyl) propionic acid. Dexibuprofen was first developed as a new type of non-steroidal anti-inflammatory drug by Austria Gebro Pharmaceutical Company. It is widely used in the treatment of rheumatoid arthritis and was launched in Austria in April 1993. It was subsequently launched in European countries such as Italy and Switzerland. [0003] Currently, nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most widely used drugs in the world. About 30 million people use it every day around the world. With the increasing use of NSAIDs, the safe use of these drugs has attracted more and more attention from clinician...

Claims

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Application Information

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IPC IPC(8): G01N30/89G01N30/34
CPCG01N30/89G01N30/34G01N2030/342
Inventor 王雪根何凌云卢敏吴清
Owner NANJING CORE TECH CO LTD
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