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Mosapride citrate related substance detection method

A technology for mosapride citrate and related substances, which is applied in the detection field of mosapride citrate related substances, can solve the problems of incomplete detection of impurities, inability to achieve accurate detection, and low degree of separation of impurities, and achieve accurate The effect of detection, large baseline fluctuation and small background interference

Active Publication Date: 2016-02-03
CHENGDU KANGHONG PHARMA GRP
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] At present, there are some reports on the high performance liquid chromatography detection method of mosapride citrate, but it can only detect some impurities, and there is a phenomenon of incomplete detection of impurities, and the separation degree of some impurities is not high, so accurate detection cannot be realized

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  • Mosapride citrate related substance detection method
  • Mosapride citrate related substance detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1 Detection of related substances of mosapride citrate

[0047] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 0.25 mg per 1 ml.

[0048] High-performance liquid chromatography detection conditions: mobile phase: 0.05mol / L citric acid solution (sodium hydroxide test solution to adjust the pH value to 3.0)-methanol (60:40), flow rate: 1ml / min; detection wavelength: 275nm; column Temperature: 35°C, injection volume is 20 μl.

[0049] Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows figure 1 As shown, the number of impurities detected by it is small, and the chromatographic peak response value is low, and the detection sensitivity is low.

Embodiment 2

[0050] The detection of the related substance of embodiment two mosapride citrate

[0051] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 0.5 mg per 1 ml.

[0052] High-performance liquid chromatography detection conditions: mobile phase: 0.05mol / L sodium dihydrogen phosphate buffer solution (adjust the pH value to 3.0 with triethylamine)-acetonitrile (72:28), flow rate: 1ml / min; detection wavelength: 276nm; column Temperature: room temperature (28°C), the injection volume is 10 μl.

[0053] Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows figure 2 As shown, the number of impurities detected by it is small, and the chromatographic peak response value is low, and the detection sensitivity is low.

Embodiment 3

[0054] Embodiment 3 Detection of Related Substances of Mosapride Citrate

[0055] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 1.0 mg per 1 ml.

[0056] High-performance liquid chromatography detection conditions: 0.1M sodium dihydrogen phosphate solution (phosphoric acid to adjust pH=4.0): methanol ratio of 75:25, flow rate: 1ml / min; detection wavelength: 274nm; column temperature: 35°C, injection volume: 10μl . Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows image 3 As shown, the impurity peak separation effect of the detection result is poor, the peak shape is asymmetrical, and the chromatographic peak response value is low, and the detection sensitivity is low.

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Abstract

The invention provides a mosapride citrate related substance detection method which comprises the step of detecting related substances in the pharmaceutical composition (mosapride citrate) through a high performance liquid chromatography and a gradient elution method. The detection method provided invention has the advantages that the number of impurities detected by the detection method is maximum, the degree of separation is relatively good, in addition, the response value is high and the sensitivity is good.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting related substances of mosapride citrate. Background technique [0002] Mosapride Citrate (MosaprideCitrate, trade name Gasmotin) is a new type of gastric motility drug developed by Dainippon Pharmaceutical Co., Ltd. It is a potent and selective 5-HT4 receptor agonist and is clinically used for the treatment of chronic gastritis, Relief of a series of gastrointestinal symptoms associated with functional dyspepsia, reflux esophagitis and surgery. It was first listed in Japan in December 1998. Its Chinese chemical name is: 4-amino-5-chloro-2-ethoxy-N-{[4-(4-fluorobenzyl)-2-morpholinyl]methanol Base} benzamide citrate; Molecular formula: C 21 h 25 ClFN 3 o 3 ·C 6 h 8 o 7 2H 2 O, molecular weight: 650.05, its structural formula is: [0003] [0004] Mosapride is a potent and selective 5-HT4 receptor agonist. It stimulates the release of acetylcholine f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 柯潇邬智刚林楠
Owner CHENGDU KANGHONG PHARMA GRP
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