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Detection method for mitiglinide calcium R-isomer

A technology of mitiglinide calcium and isomers, which is applied in the identification field of mitiglinide calcium R-isomers, can solve the problem that the resolution cannot meet legal requirements and the like, and achieves excellent detection effect, good stability, No trailing effect

Active Publication Date: 2019-12-13
JIANGXI JINSHUIBAO PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This new technology helps improve the quality control (QC) process by making it easier to detect any issues with samples that may be harmful or useful during testing. It also provides stable results without causing peaks at certain locations within each sample being analyzed. Overall, this innovative technology makes analysis faster and reliable over time while reducing errors caused due to poorly prepared solutions used earlier.

Problems solved by technology

This patented describes two different ways for controlling the levels or amounts of specific compounds found naturally occurring during various metabolism processes such as gastronadotropic hormone production that affect glucose homeostasis. These techniques include detecting these compound molecules through mass spectetry analysis, identifying their structures based upon similarity patterns, studying how they interact with other components involved in regulation mechanisms like protein kinase activity, measuring changes caused by enzyme activation, and developing systems suitable for use in clinics due to improved accuracy compared to current assays.

Method used

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  • Detection method for mitiglinide calcium R-isomer
  • Detection method for mitiglinide calcium R-isomer
  • Detection method for mitiglinide calcium R-isomer

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0073] Chromatographic conditions and system suitability test:

[0074] Chromatographic column: chiral chromatographic column Ultimate Amy-DR (250×4.6mm 5μm);

[0075] Mobile phase: acetonitrile-trifluoroacetic acid (100:0.1);

[0076] Detection wavelength: 210nm.

[0077] Flow rate: 0.3ml / min

[0078] Column temperature: 30°C

[0079] Preparation of the test solution: Take an appropriate amount of the test product, weigh it accurately, add mobile phase to make a solution containing 0.2 mg per 1 ml, and shake well to obtain.

[0080] Preparation of mitiglinide calcium reference substance solution: Take an appropriate amount of the reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[0081] Preparation of R-isomer reference substance solution: Take an appropriate amount of R-isomer reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[00...

example 2

[0085] Chromatographic conditions and system suitability test:

[0086] Chromatographic column: chiral chromatographic column Ultimate Amy-DR (250×4.6mm 5μm);

[0087] Mobile phase: acetonitrile-trifluoroacetic acid (100:0.1);

[0088] Detection wavelength: 210nm.

[0089] Flow rate: 0.5ml / min

[0090] Column temperature: 30°C

[0091] Preparation of the test solution: Take an appropriate amount of the test product, weigh it accurately, add mobile phase to make a solution containing 0.2 mg per 1 ml, and shake well to obtain.

[0092] Preparation of mitiglinide calcium reference substance solution: Take an appropriate amount of the reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[0093] Preparation of R-isomer reference substance solution: Take an appropriate amount of R-isomer reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[00...

example 3

[0097] Chromatographic conditions and system suitability test:

[0098] Chromatographic column: chiral chromatographic column Ultimate Amy-DR (250×4.6mm 5μm);

[0099] Mobile phase: acetonitrile-trifluoroacetic acid (100:0.1);

[0100] Detection wavelength: 210nm.

[0101] Flow rate: 0.8ml / min

[0102] Column temperature: 30°C

[0103] Preparation of the test solution: Take an appropriate amount of the test product, weigh it accurately, add mobile phase to make a solution containing 0.2 mg per 1 ml, and shake well to obtain.

[0104] Preparation of mitiglinide calcium reference substance solution: Take an appropriate amount of the reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[0105] Preparation of R-isomer reference substance solution: Take an appropriate amount of R-isomer reference substance, weigh it accurately, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well.

[01...

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Abstract

The invention relates to a detection method for mitiglinide calcium R-isomer. According to the method, high performance liquid chromatography is adopted. The method comprises the following steps of: 1) the preparation of a test sample solution: a proper amount of a mitiglinide calcium bulk pharmaceutical chemical test sample is taken, and is precisely weighed, a mobile phase is added to the mitiglinide calcium bulk pharmaceutical chemical test sample, so that a solution containing 0.2 mg of the mitiglinide calcium bulk pharmaceutical chemical test sample per 1ml can be prepared, and the solution is uniformly shaken, so that the test sample solution can be obtained; 2) the preparation of a mitiglinide calcium reference substance solution: a proper amount of mitiglinide calcium reference substance is taken, is precisely weighed, a mobile phase is added to the mitiglinide calcium reference substance, so that a solution containing 0.2 mg of the mitiglinide calcium reference substance per 1ml can be prepared, and the solution is uniformly shaken, so that the mitiglinide calcium reference substance solution is obtained; and (3) the preparation of a mitiglinide calcium R-isomer referencesubstance solution: a proper amount of mitiglinide calcium R-isomer reference substance is taken, and is precisely weighed, a mobile phase is added, so that a solution containing 0.2 mg of mitiglinidecalcium R-isomer reference substance per 1ml can be prepared, and the solution is uniformly shaken, so that the mitiglinide calcium R-isomer reference substance solution can be obtained; and 4) determination: 20 microliters of the solutions in the step 1), the step 2) and the step 3) are separately injected into a high performance liquid chromatograph, so that chromatograms can be obtained, and the content of the mitiglinide calcium R-isomer in the mitiglinide calcium bulk pharmaceutical chemical is calculated according to peak areas in the chromatograms and through a normalization method.

Description

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Claims

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Application Information

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Owner JIANGXI JINSHUIBAO PHARM CO LTD
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