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High performance liquid chromatography detection method for parecoxib sodium isomer

A parecoxib sodium and detection method technology, which is applied in the field of drug synthesis and detection, can solve problems such as no clear reference meaning, and achieve the effects of good production quality control, good repeatability, and accurate quantification

Active Publication Date: 2015-10-07
CHENGDU CLIMB PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no clear reference between the HPLC detection conditions of different compounds

Method used

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  • High performance liquid chromatography detection method for parecoxib sodium isomer
  • High performance liquid chromatography detection method for parecoxib sodium isomer
  • High performance liquid chromatography detection method for parecoxib sodium isomer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] [Example 1] A high-performance liquid chromatography detection method of parecoxib sodium isomers, using silane-bonded silica gel as a chromatographic column as a filler, using n-hexane-isopropanol as a mobile phase of parecoxib Sodium is separated and detected, and the volume ratio of the mobile phase n-hexane-isopropanol is 70:30.

[0024] The chromatographic column is Agela Technologies silica 4.6×250 mm, 5 μm.

[0025] The flow rate of the mobile phase is 1.0ml / min, the temperature of the chromatographic column is 35°C, and the detection wavelength is 215nm.

[0026] The detection method of parecoxib sodium isomer comprises the following steps:

[0027] S1. Preparation of the test solution: get an appropriate amount of test sample, accurately weighed, and make a solution containing 0.4 mg of parecoxib per 1 ml with the diluent as the test solution;

[0028] S2. Preparation of reference substance solution: take appropriate amount of parecoxib isomer reference subst...

Embodiment 2

[0031] [Example 2] A high-performance liquid chromatography detection method of parecoxib sodium isomers, using silane-bonded silica gel as a chromatographic column as a filler, using n-hexane-isopropanol as a mobile phase of parecoxib Sodium is separated and detected, and the volume ratio of the mobile phase n-hexane-isopropanol is 80:20.

[0032] The chromatographic column is Agela Technologies silica 4.6×250 mm, 5 μm.

[0033] The flow rate of the mobile phase is 0.8ml / min, the temperature of the chromatographic column is 30°C, and the detection wavelength is 215nm.

[0034] The detection method of parecoxib sodium isomer comprises the following steps:

[0035] S1. Preparation of the test solution: take an appropriate amount of the test sample, accurately weigh it, and use a diluent to make a solution containing 0.4 mg of parecoxib per 1 ml as the test solution. The diluent is n-hexane-iso Propanol, the volume ratio is 50:50;

[0036] S2. Preparation of reference substan...

Embodiment 3

[0039] [Example 3] A high-performance liquid chromatography detection method of parecoxib sodium isomers, using silane-bonded silica gel as a chromatographic column as a filler, using n-hexane-isopropanol as a mobile phase of parecoxib Sodium is separated and detected, and the volume ratio of the mobile phase n-hexane-isopropanol is 90:10.

[0040] The chromatographic column is Agela Technologies silica 4.6×250 mm, 5 μm.

[0041] The flow rate of the mobile phase is 0.7ml / min, the temperature of the chromatographic column is 40°C, and the detection wavelength is 215nm.

[0042] The detection method of parecoxib sodium isomer comprises the following steps:

[0043] S1. Preparation of the test solution: get an appropriate amount of test sample, accurately weighed, and make a solution containing 0.4 mg of parecoxib per 1 ml with the diluent as the test solution;

[0044] S2. Preparation of reference substance solution: take appropriate amount of parecoxib isomer reference subst...

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Abstract

The invention discloses a high performance liquid chromatography detection method for a parecoxib sodium isomer. The method uses a chromatographic column with silane bonded silica gel as the filler, and adopts n-hexane-isopropanol as the mobile phase to conduct separation and detection on parecoxib sodium, the volume ratio of the mobile phase n-hexane-isopropanol is 70-95:5-30, and the chromatographic conditions include: a mobile phase flow rate of 0.6-1.0ml / min, a chromatographic column temperature of 30DEG-40DEG C, and a detection wavelength of 215nm. The method specifically includes the steps of: S1. preparation of a test solution; S2. preparation of a reference solution; and S3. detection. The detection method provided by the invention has the advantages of simplicity and rapidity, accurate quantification and good repeatability, can accurately separate and detect a parecoxib sodium structure isomer, and plays a good promoting role in research and synthesis, and production quality control of parecoxib sodium.

Description

technical field [0001] The invention belongs to the field of drug synthesis and detection, and relates to a high performance liquid chromatography detection method for isomers of parecoxib sodium. Background technique [0002] Parecoxib sodium chemical name: N-[[4-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]propionamide sodium salt, white or off-white freeze-dried Lumps. It is currently on the market in Europe and is mainly used for short-term treatment after surgery. It can be used clinically for the treatment of moderate or severe postoperative acute pain. [0003] The isomer of parecoxib sodium is the structural isomer (position isomer) of parecoxib sodium, which is the meta-isomerization produced on the benzene ring during the first step of sulfonation in the synthesis of this product. Due to the position of the functional group Its biological activity may also be different according to different species. Therefore, it is an important part of the quality control of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 张勇李娟刘静郭瑞
Owner CHENGDU CLIMB PHARMA TECH
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