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Method for separating and determining oxiracetam and midbody of oxiracetam by utilizing liquid chromatography

A determination method, liquid chromatography technology, applied in the field of separation and determination of oxiracetam and its intermediate content by liquid chromatography, can solve the problems of no vascular activity, no central excitatory effect, etc., and achieve the effect of ensuring quality control

Active Publication Date: 2015-04-01
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug itself has no direct vascular activity, nor does it have a central stimulating effect, and its effect on learning and memory is a lasting promotion effect.

Method used

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  • Method for separating and determining oxiracetam and midbody of oxiracetam by utilizing liquid chromatography
  • Method for separating and determining oxiracetam and midbody of oxiracetam by utilizing liquid chromatography
  • Method for separating and determining oxiracetam and midbody of oxiracetam by utilizing liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Instruments and Conditions

[0038] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0039] Column: C 8 (Apollo, 250×4.6mm, 5μm)

[0040] Mobile phase: A phase: 0.06% perchloric acid, pH 2.5, B phase: methanol, using isocratic elution; A: B=90:10

[0041] Flow rate: 1.0mL / min

[0042] Detection wavelength: 205nm

[0043] Injection volume: 10μL

[0044] Experimental procedure

[0045] Take an appropriate amount of oxiracetam and its intermediates, dissolve the samples in 80% acetonitrile water, respectively, and prepare a sample solution containing about 0.5 mg / mL of oxiracetam and its intermediates. Perform HPLC analysis according to the above conditions, and record the chromatograms. see attached results Figure 1~2 ; figure 1 The chromatographic peak whose retention time is 3.287min is oxiracetam; figure 2 The No. 2 peak in the middle is oxiracetam, and the peak eluting time of oxiracetam is 3.421min, and...

Embodiment 2

[0047] Instruments and Conditions

[0048] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0049] Column: C 18 (Unitary, 250×4.6mm, 5μm)

[0050] Mobile phase: A phase: 0.01M sodium heptanesulfonate solution: methanol=95:5, pH 2.6; B phase: acetonitrile, isocratic elution;

[0051] A:B=90:10

[0052] Flow rate: 1.0mL / min

[0053] Detection wavelength: 205nm

[0054] Column temperature: 20°C

[0055] Injection volume: 10μL

[0056] Experimental procedure

[0057] Take an appropriate amount of oxiracetam and its intermediates, dissolve the sample with 0.01M sodium heptanesulfonate solution:methanol=90:10, and prepare a sample solution containing about 0.5 mg / mL of oxiracetam and its intermediates; Another appropriate amount of 0.01M sodium heptanesulfonate solution: methanol = 90:10 was used as a blank solvent. Perform HPLC analysis according to the above conditions, and record the chromatograms. see attached result...

Embodiment 3

[0059] Instruments and Conditions

[0060] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0061] Column: C 18 (Apollo, 250×4.6mm, 5μm)

[0062]Mobile phase: A phase: 0.01M sodium heptanesulfonate solution, pH 2.8, B phase: methanol: pure water=1:1; A:B=93:7

[0063] Flow rate: 1.0mL / min

[0064] Detection wavelength: 205nm

[0065] Column temperature: 20°C

[0066] Injection volume: 10μL

[0067] Experimental procedure

[0068] Take an appropriate amount of oxiracetam and its intermediates, dissolve the sample with 0.01M sodium heptanesulfonate solution:methanol=90:10, and prepare a sample solution containing about 0.5 mg / mL of oxiracetam. Perform HPLC analysis according to the above conditions, and record the chromatograms. see attached results Figure 5~6 , Figure 5 is the solvent peak, Figure 6 The chromatographic peak whose retention time is 3.664min is oxiracetam, and the rest of the chromatographic peaks...

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Abstract

The invention belongs to the field of analytical chemistry, and discloses a method for separating and determining oxiracetam and a midbody of the oxiracetam by utilizing liquid chromatography. The method is characterized in that octadecyl silane bonded silica gel is used as a chromatographic column of filler, an organic phase with a given ratio of ion to reagent is adopted as a mobile phase, the content of each midbody in the oxiracetam can be quantitatively determined, so that the quality of the oxiracetam can be effectively controlled. According to the method, the exclusiveness is strong, the accuracy is high, and the operation is simple and convenient.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring the content of oxiracetam and its intermediates by liquid chromatography. Background technique [0002] Oxiracetam is a new type of central nervous system drug that promotes learning and memory. The active ingredient is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which can activate, protect or promote the functional recovery of nerve cells. , Improving the memory and learning functions of mentally handicapped patients. The drug itself has no direct vasoactive effect, nor does it have a central stimulating effect, and its effect on learning and memory is a lasting promotion effect. Oxiracetam, the chemical name is 2-(4-hydroxypyrrolidin-2-one-1-yl)acetamide, and the English common name is Oxiracetam. Molecular formula is C 6 h 10 N 2 o 3 . The structural formula of oxiracetam is: [0003] . [0004] In the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王晓莹王宇杰马苏峰
Owner 万全万特制药(厦门)有限公司
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