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Analysis and detection method for oxiracetam and impurities thereof

A quality analysis and high performance liquid chromatography technology, which is applied in the analysis field of liquid chromatography for the separation and determination of oxiracetam and its various known impurities, and can solve the problem of failure to detect degradation peaks, non-degradable peaks and known impurities. Impurity separation and other issues to achieve the effect of ensuring controllable quality and ensuring stability

Active Publication Date: 2013-05-01
北京元延医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We verified the method with oxiracetam, and the results showed that this method could not separate the degradation peaks from the known impurities well in the sample degradation test, and failed to detect all the degradation peaks

Method used

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  • Analysis and detection method for oxiracetam and impurities thereof
  • Analysis and detection method for oxiracetam and impurities thereof
  • Analysis and detection method for oxiracetam and impurities thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Instruments and conditions:

[0063] Shimadzu LC-10ATvp high performance liquid chromatograph and Shimadzu workstation; Octadecylsilane bonded silica gel column (AQ-C18, 4.6mm×25cm×5μm, Yuexu); methanol as the flow Phase A, with phosphate buffer (preparation of 0.05mol / L potassium dihydrogen phosphate solution, adjust the pH value to 3.0 with phosphoric acid) as mobile phase C, the mobile phase is mobile phase A methanol and mobile phase C phosphate buffer according to parts by volume The ratio of 1:99 is prepared; the detection wavelength is 210nm; the column temperature is 35°C. Mobile phase flow rate: 0.5ml / min, liquid phase analysis injection volume: 20μl.

[0064] experiment procedure:

[0065] Weigh 10mg of oxiracetam raw material, put it in a 10ml measuring bottle, add mobile phase, dissolve and dilute to the mark, shake well, filter to obtain the solution to be analyzed.

[0066] Precisely draw 20 μl of the solution to be analyzed, carry out chromatographic a...

Embodiment 2

[0069] Instruments and conditions:

[0070] Shimadzu LC-10ATvp high-performance liquid chromatograph and the workstation of Shimadzu; Chromatographic column (C8, 4.6mm * 25cm * 5 μ m, Yuexu); With methanol as mobile phase A, with phosphate buffer (preparation of 0.05mol / L Potassium dihydrogen phosphate solution, adjusted pH value to 3.0 with phosphoric acid) is mobile phase C, and mobile phase is mobile phase A methanol and mobile phase C phosphate buffer according to the ratio preparation of volume part 1:99; Detection wavelength is 210nm; Column temperature is 35°C. Mobile phase flow rate: 0.5ml / min, liquid phase analysis injection volume: 20μl.

[0071] experiment procedure:

[0072] Weigh 10mg of oxiracetam raw material, put it in a 10ml measuring bottle, add mobile phase, dissolve and dilute to the mark, shake well, filter to obtain the solution to be analyzed.

[0073] Precisely draw 20 μl of the solution to be analyzed, carry out chromatographic analysis according to...

Embodiment 3

[0076] Instruments and conditions:

[0077] Shimadzu LC-10ATvp high performance liquid chromatograph and Shimadzu workstation; Octadecylsilane bonded silica gel as filler column (AQ-C18, 4.6mm×25cm×5μm, Yuexu); mobile phase is phosphoric acid Buffer (prepare 0.05 mol / L potassium dihydrogen phosphate solution, adjust pH value to 3.0 with phosphoric acid); detection wavelength is 210nm; column temperature is 35°C. Mobile phase flow rate: 0.5ml / min, liquid phase analysis injection volume: 20μl.

[0078] experiment procedure:

[0079] Weigh 10mg of oxiracetam raw material, put it in a 10ml measuring bottle, add mobile phase, dissolve and dilute to the mark, shake well, filter to obtain the solution to be analyzed.

[0080] Precisely draw 20 μl of the solution to be analyzed, carry out chromatographic analysis according to the above-mentioned chromatographic conditions, and record the chromatogram (the recording time is more than 3 times the retention time of the main peak), and ...

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Abstract

The invention relates to an analysis and detection method for materials related to oxiracetam, in particular to an oxiracetam quality analysis method. The method comprises the steps of adopting a high performance liquid chromatography to perform quality analysis for oxiracetam drug substances or pharmaceutical preparations containing the oxiracetam. According to the invention, the adopted chromatographic column is a C18 or C8 chromatographic column at the temperature of 30-40 DEG C. Besides, the adopted high performance liquid chromatography can effectively separate the oxiracetam and the impurities thereof under a certain chromatographic condition. Therefore, through the method, the content of each impurity in the oxiracetam can be accurately measured.

Description

technical field [0001] The invention belongs to the field of pharmaceutical analytical chemistry, and relates to a method for analyzing the quality of a nootropic drug oxiracetam, in particular to an analysis method for separating and measuring oxiracetam and various known impurities thereof by liquid chromatography (HPLC). Background technique [0002] Oxiracetam (Oxiracetam, CAS62613-82-5), chemically named 2-(4-hydroxypyrrolidin-2-one-1-yl) acetamide, is a new type of central nervous system that promotes learning and memory Drug, the active ingredient is a synthetic hydroxyaminobutyric acid (BABOB) cyclic derivative, only acts on the central nervous system, mainly distributed in the cerebral cortex and hippocampus, can activate, protect or promote the functional recovery of nerve cells, improve The memory and learning function of patients with mental retardation, while the drug itself has no direct vasoactive activity, nor central excitatory effect, the effect on learning...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王立强刘洪亮
Owner 北京元延医药科技股份有限公司
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