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Method for detecting acarbose through high performance liquid chromatography

A high-performance liquid chromatography and acarbose technology, which is applied in the field of high-performance liquid chromatography to detect acarbose, can solve the problems of inconvenient analysis work, long running time, column loss and the like, and achieves simple mobile phase preparation, Realize the effect of quality control and good quality control

Active Publication Date: 2016-05-11
SICHUAN LVYE BAO GUANG PHARMA IND
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AI Technical Summary

Problems solved by technology

These methods are mainly aimed at acarbose or acarbose metabolites, etc., and do not solve the problems of poor separation of acarbose and its impurities, large interference of related substances, and serious column loss.
[0006] In the existing acarbose detection method, acarbose cannot be completely separated from impurity A, and the product quality of acarbose cannot be better controlled; and the existing detection method has fast flow rate, long running time, and large reagent consumption ; and the bonded phase of the amino column is easy to lose, the life of the chromatographic column is short, which brings inconvenience to the analysis work, and a series of problems such as high detection cost

Method used

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  • Method for detecting acarbose through high performance liquid chromatography
  • Method for detecting acarbose through high performance liquid chromatography
  • Method for detecting acarbose through high performance liquid chromatography

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Embodiment 1

[0077] 1 Preparation of solution

[0078] 1.1 Spare buffer solution and mobile phase

[0079] 200mM ammonium formate buffer salt (pH3.0): Weigh 12.6g of ammonium formate into a 1L volumetric flask, add appropriate amount of water to dissolve, add 25mL of formic acid, mix well, add water to make up to the mark.

[0080] 200mM ammonium acetate buffer salt (pH6.8): Weigh 15.4g of ammonium acetate into a 1L volumetric flask, add water to dissolve to volume.

[0081] 200mM ammonium acetate buffer salt (pH9.0): Weigh 15.4g of ammonium acetate into a 1L volumetric flask, add appropriate amount of water to dissolve, add 8mL of ammonia water, mix well, add water to make up to the mark.

[0082] Each mobile phase is obtained by diluting the corresponding backup buffer solution in proportion with 75% acetonitrile water. For example, to prepare 1L of mobile phase containing 10mM ammonium acetate (pH9.0), add 50mL of 200mM ammonium acetate buffer salt (pH9.0) to 750mL of acetonitrile and...

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Abstract

The invention relates to a method for detecting acarbose through high performance liquid chromatography. The chromatographic conditions are as follows: chromatographic column: XBridge Amide column (waters, 4.6mm*250mm, 3.5mu m); mobile phase: organic phase-water phase; flow velocity: 1.0-1.4mL / min; detection wavelength: 210nm; column temperature: 60-70 DEG C; sample size: 10-20mu l. An ultraviolet detector is adopted as a detector; the volume ratio of organic phase to water phase in the mobile phase is (75:25)-(80:20); acetonitrile is taken as the organic phase in the mobile phase; ammonium acetate is contained in the mobile phase; the concentration range of ammonium acetate is 5-10mM and pH range is 5.0-10.0. Compared with the existing method, the method has the advantages that the complete separation of acarbose and impurity A is realized, another unknown impurity can be additionally separated and the product quality of the acarbose can be preferably controlled.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for detecting acarbose by high performance liquid chromatography. Background technique [0002] Acarbose is an oligosaccharide composed of four monosaccharides isolated from actinomycetes. It has a competitive inhibitory effect on α-glucosidase at the brush border of small intestinal wall cells, and can hinder intestinal It can hydrolyze the polysaccharides and oligosaccharides in the intestinal tract, thereby reducing the absorption of monosaccharides in the small intestine and achieving the purpose of reducing postprandial blood sugar concentration. It is one of the commonly used drugs for type II diabetes. [0003] The 2015 edition of the Chinese Pharmacopoeia added the quality standards for acarbose, and the method for its content determination was high performance liquid chromatography, which was consistent with the method included in the European Pharmacopoeia. The me...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 许丽晓耿银银刘万卉孟莹
Owner SICHUAN LVYE BAO GUANG PHARMA IND
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