Method for detecting content of amino acids and glycyl glutamine in compound amino acid (15) dipeptide (2) injection solution

Abstract

The invention discloses a method for detecting the content of amino acids and glycyl glutamine in a compound amino acid (15) dipeptide (2) injection solution. The method comprises the following steps: precisely taking a detected sample and a reference substance solution, injecting the detected sample and the reference substance solution into a chromatographic instrument with a sulfonic group storng acid cation exchange resin LCAK06/Na column, carrying out gradient elution and regeneration balance by a mobile phase buffer solution A, a mobile phase buffer solution B and a regeneration solution, carrying out post-column derivative reaction by a derivatization reagent ninhydrin solution, recording a chromatogram map under detection wavelengths of 440nm and 570nm, and calculating according to the peak area by an external standard method. The method is capable of simultaneously detecting the content of fifteen amino acids and glycyl glutamine, and has the advantages of low cost, high speed and high sensitivity; the results of the careful methodology validation show that the method can be used for simultaneously detecting the content of amino acids and glycyl glutamine in the compound amino acid (15) dipeptide (2) injection solution; the change of the content of fifteen main chemicals in a stable sample can be inspected.

Description

technical field [0001] The invention relates to a method for detecting the content of an amino acid preparation, in particular to a method for detecting the content of amino acids and glycylglutamine in compound amino acid (15) dipeptide (2) injection. Background technique [0002] Compound amino acid (15) dipeptide (2) injection is a sterilized aqueous solution composed of 15 kinds of amino acids and 2 kinds of dipeptides. The prescription is that every 1000ml contains: L-alanine (C 3 h 7 NO 2 ) 16.00g, L-arginine (C 6 h 14 N 4 o 2 ) 11.30g, L-aspartic acid (C 4 h 7 NO 4 ) 3.4g, L-glutamic acid (C 5 h 9 NO 4 ) 5.60g, L-histidine (C 6 h 9 N 3 o 2 )6.80g, L-isoleucine (C 6 h 13 NO 2 ) 5.60g, L-leucine (C 6 h 13 NO 2 )7.90g, L-lysine acetate (C 6 h 14 N 2 o 2 ·C 2 h 4 o 2 )12.70 g , L-methionine (C 5 h 11 NO 2 S) 5.60g, L-phenylalanine (C 9 h 11 NO 2 ) 5.85g, L-proline (C 5 h 9 NO 2 ) 6.80g, L-serine (C 3 h 7 NO 3 ) 4.50g, L-threonine (...

AI Technical Summary

Problems solved by technology

[0004] Due to the complexity of the components in the compound amino acid (15) dipeptide (2) injection, it is difficult to quantitatively analyze the components

Prior art such as Chinese patent CN103134892A discloses the analysis method of compound amino acid (15) dipeptide (2) injection, adopts high performance liquid chromatography detection method, and chromatographic condition is the reverse reaction that adopts octadecylsilane bonded silica gel as filler. Phase chromatographic column detection, the detection wavelength is 265-280nm, the mobile phase is composed of mobile phase A and mobile phase B, mobile phase A is methanol, mobile phase B is an aqueous solution with a pH value of 2.0-4.0 adjusted by a buffer solution, but this method Just the content of tryptophan and glycyl-tyrosine of determination; People such as Ye Xiaolin are in " the content determination of two components in compound amino acid (15) dipeptide (2) injection " (China Pharmaceutical Industry, 2008 07 Issue) reported the determination of two peptides in amino acid (15) dipeptide (2) injection, glycyl-glutamine (GQ) and glycyl-tyrosine (GY) by reversed-phase high performance chromatography content, the method disclosed in this document uses acetonitrile and 0.05mol / L sodium dihydrogen phosphate solution as the mobile phase, adopts the gradient elution method, and also uses FDNB to carry out pre-column derivatization treatment. Complicated, with many operation steps, and the content of fifteen amino acids cannot be detected at the same time

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