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Method for measuring propylamine glutamine content

A technology of alanylglutamine and content, applied in the field of chromatographic analysis, can solve the problems of poor peak shape, late peak time, and poor separation effect of alanylglutamine, and achieve good elution and separation effect and accurate results Reliable, simple and fast results

Inactive Publication Date: 2013-09-11
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the one hand, due to the weak stability of alanyl-glutamine, when the above three mobile phases are used for determination, the separation effect is poor or the peak time is late, which is not conducive to the content control of alanyl-glutamine; on the other hand , in the State Food and Drug Administration standard YBH06582005, the peak shape of alanyl glutamine is poor, there is a certain error in the detection, and the time is long

Method used

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  • Method for measuring propylamine glutamine content
  • Method for measuring propylamine glutamine content
  • Method for measuring propylamine glutamine content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Instruments and Conditions

[0022] High performance liquid chromatography: Waters2695 pump; Waters2487 UV detector

[0023] Chromatographic column: Octadecylsilane bonded silica gel column (250mmx4.6mm, 5μm)

[0024] Mobile phase: acetonitrile-0.05mol / L potassium dihydrogen phosphate buffer (pH4.0) (65:35) isocratic elution

[0025] Flow rate: 1.0ml / min

[0026] Detection wavelength: 215nm

[0027] Column temperature: 40°C

[0028] Injection volume: 20μl

[0029] Implementation steps

[0030] Accurately measure 5ml of this product, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, then precisely measure 5ml, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as the test solution (Make a solution containing 0.5mg per 1ml). Take 20μl into the liquid chromatograph and record the chromatogram; another precisely weigh about 25mg of the L-alanyl-L-glutamine reference substance that h...

Embodiment 2

[0035] Instruments and Conditions

[0036] High performance liquid chromatography: Waters2695 pump; Waters2487 UV detector

[0037] Chromatographic column: Octadecylsilane bonded silica gel column (250mmx4.6mm, 5μm)

[0038] Mobile phase: add water to 5ml of acetonitrile-triethylamine to 1000ml (adjust pH to 5.5 with phosphoric acid) = 40:60, etc.

[0039] degree of elution

[0040] Column temperature: 40°C

[0041] Flow rate: 1.0ml / min

[0042] Detection wavelength: 245nm

[0043] Derivative reagents: 400ml of phenyl isothiocyanate, 400ml of triethylamine, 2800ml of absolute ethanol, 400ml of ultrapure water, mix well, and prepare freshly before use. The flow rate is 0.25ml / min

[0044] Injection volume: 20μl

[0045] Accurately measure 5ml of this product, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, then precisely measure 5ml, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it ...

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Abstract

The invention discloses a method for measuring the propylamine glutamine content, belonging to the field of chromatographic analysis. In the method, octadecylsilane bonded silica is utilized as a chromatographic column stuffing, a mixed solvent of an organic phase and an aqueous phase of a phosphate buffer solution are utilized as mobile phases, and phenyl isothiocyanate is utilized as a derivatization reagent, wherein the organic phase is acetonitrile or methanol; the phosphate buffer solution is prepared in the following manner: adding water in 5ml of triethylamine to 1000ml, and adjusting the pH to 5.0-6.0 through phosphoric acid; in the mobile phase, the percent by volume of the aqueous phase is 30-50%. Compared with the prior art, the measuring method provided by the invention has the advantages of high analysis sensitivity, accurate and reliable result, and the like, thereby having good popularization and application values in the production field of propylamine glutamine injection.

Description

technical field [0001] The invention relates to the field of chromatographic analysis, in particular to a method for determining alanyl glutamine by post-column derivatization high performance liquid chromatography in the production process of alanyl glutamine injection. Background technique [0002] N(2)-L-alanyl-L-glutamine (alanylglutamine dipeptide, Ala-Gln), as a glutamine (glutamine, Gln) donor, makes up for the lack of Gln, expanding its clinical role as Application range of parenteral nutrition preparations. Alanylglutamine is a component of parenteral nutrition for patients requiring glutamine supplementation, including those in catabolic and hypermetabolic conditions. [0003] [0004] Molecular formula: C 8 h 15 N 3 o 4 , molecular weight: 188.18 [0005] In the prior art, high-efficiency chromatography is one of the important assay methods for measuring alanyl-glutamine, such as the State Food and Drug Administration standard YBH06582005, using amino-bon...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王玉真李大涛杜振新
Owner CISEN PHARMA
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