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Compounded amino acid injection 18AA-II content measurement method

A technology of compound amino acid and determination method, which is applied in the field of content determination of compound amino acid injection 18AA-II, can solve the problems of failing to meet the requirements of component separation, poor reproducibility, poor accuracy of content determination results, etc., reaching good separation effect

Active Publication Date: 2016-05-18
HUAREN PHARMACEUTICAL CO LTD
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  • Description
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Problems solved by technology

[0006] However, when using an amino acid analyzer to determine the content of compound amino acid injection (18AA-II), since the content of cystine is small, and the peak time of cystine is just around the mobile phase conversion time, the separation of the instrument itself The test was carried out under certain conditions, resulting in poor analysis results of cystine and valine, which failed to meet the requirements of the test for component separation. At the same time, the content of cystine fluctuated greatly, resulting in poor accuracy and poor reproducibility of the content determination results.

Method used

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Embodiment Construction

[0019] The specific embodiment of the present invention is further described below in conjunction with the examples as follows, and the separation spectrum is as follows figure 2 Shown:

[0020] Using Hitachi L-8900 Amino Acid Analyzer

[0021] Test sample: compound amino acid injection (18AA-II) (produced by Huaren Pharmaceutical Co., Ltd.)

[0022] Reference substance: sourced from China Inspection Institute, batch number 140624-200805, purity 100%;

[0023] Column pressure: The column pressure of pump 1 is about 11Mpa, and the column pressure of pump 2 is 2.0Mpa;

[0024] Loading volume: 10μL

[0025] An ion-exchange resin column (purchased from Hitachi) was used, the column temperature was 57°C, the flow rate was 0.4ml / min, the detection wavelength was 570nm and 440nm, the mobile phase was composed of buffers B1, B2, B3, B4, and B5, and the elution time was 100% B1 for 0-2.5 minutes, 100% B2 for 2.6-5 minutes, 100% B3 for 5.1-13.6 minutes, 100% B3 for 13.7-27.8 minute...

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Abstract

The invention relates to the field of medicine preparation and especially relates to a compounded amino acid injection 18AA-II content measurement method. According to the method, when the time of conversion of a buffer solution from B2 to B3 is pushed back by 0.5 min, the time of conversion of a buffer solution from B3 to B4 is pushed back by 0.8 min, and the temperature of a separation column reaches 57 DEG C, a better separation effect between the components is achieved and further separation degree between cystine and valine satisfies the demand on content measurement, and meanwhile, interference on the cystine due to conversion of a mobile phase is reduced, so that accurate quantitative measurement is achieved even under a low content, and finally, accurate measurement of contents of sixteen amino acids in the compounded amino acid injection 18AA-II with an amino acid analyzer can be achieved.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a method for determining the content of compound amino acid injection 18AA-II. Background technique [0002] Amino acid is the basic structural unit of protein and an important substance in the process of biological metabolism. Amino acid analysis technology is of great significance to protein chemistry, biochemistry and the whole life science research, product development, quality control and production management, etc., and is widely used in food processing , Analysis of medicine, food, health products, etc. in the medical and health industry. Its analysis and determination methods can be divided into chemical analysis, electrochemical analysis, spectrophotometry, etc. according to the detection method; according to the sequence of derivatization reactions, it can be divided into pre-column derivatization and post-column derivatization. [0003] Among the above analytical...

Claims

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Application Information

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IPC IPC(8): G01N30/06
Inventor 孔文静陆宇刘春霞邹姗姗
Owner HUAREN PHARMACEUTICAL CO LTD
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