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Method for detecting content of N, N'-diacetyl-L-cystine in compound amino acid injection

A compound amino acid and diacetyl technology, which can be used in measuring devices, instruments, scientific instruments, etc., can solve problems such as compound amino acid injection that has not yet been seen, and achieve good reproducibility.

Pending Publication Date: 2020-08-25
费森尤斯卡比华瑞制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no report on the detection method of N,N'-diacetyl-L-cystine in compound amino acid injection

Method used

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  • Method for detecting content of N, N'-diacetyl-L-cystine in compound amino acid injection
  • Method for detecting content of N, N'-diacetyl-L-cystine in compound amino acid injection
  • Method for detecting content of N, N'-diacetyl-L-cystine in compound amino acid injection

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Embodiment 1

[0032] A method for detecting N,N'-diacetyl-L-cystine content in compound amino acid injection by high performance liquid chromatography, comprising the following steps:

[0033] Step 1, first weigh sodium dihydrogen phosphate dihydrate and then add water to prepare a sodium dihydrogen phosphate buffer solution with a concentration of 20mM, then use phosphoric acid to adjust the pH value of the sodium dihydrogen phosphate buffer solution to 2.3, and finally add sodium dihydrogen phosphate The buffer solution and acetonitrile are mixed according to the volume ratio of 94:6 to form a mobile phase;

[0034] Step 2: Accurately weigh 64.11 mg of N,N'-diacetyl-L-cystine reference substance and place it in a 100mL measuring bottle, dissolve it with an appropriate amount of water and dilute to the highest mark to obtain N,N'-diacetyl-L-cystine - Cystine reference substance stock solution; accurately pipette 1ml of N,N'-diacetyl-L-cystine reference substance stock solution into a 50ml ...

Embodiment 2

[0044] A method for detecting N,N'-diacetyl-L-cystine content in compound amino acid injection by high performance liquid chromatography, comprising the following steps:

[0045] Step 1, first weigh sodium dihydrogen phosphate dihydrate and then add water to prepare a sodium dihydrogen phosphate buffer solution with a concentration of 20mM, then use phosphoric acid to adjust the pH value of the sodium dihydrogen phosphate buffer solution to 2.1, and finally add sodium dihydrogen phosphate The buffer solution and acetonitrile are mixed according to the volume ratio of 94:6 to form a mobile phase;

[0046] Step 2, the compound amino acid injection is diluted with water and used as the test solution, and the dilution factor is 5;

[0047] Step 3. The product parameters of the chromatographic column of the high performance liquid chromatograph are 150mm×4.6mm, 5μm C18 chromatographic column, the column temperature is set to 35°C, the detection wavelength is set to 210nm, the flow ...

Embodiment 3

[0052] A method for detecting N,N'-diacetyl-L-cystine content in compound amino acid injection by high performance liquid chromatography, comprising the following steps:

[0053] Step 1, first weigh sodium dihydrogen phosphate dihydrate and then add water to prepare a sodium dihydrogen phosphate buffer solution with a concentration of 20mM, then use phosphoric acid to adjust the pH value of the sodium dihydrogen phosphate buffer solution to 2.5, and finally add sodium dihydrogen phosphate The buffer solution and acetonitrile are mixed according to the volume ratio of 94:6 to form a mobile phase;

[0054] Step 2, the compound amino acid injection is diluted with water and used as the test solution, and the dilution factor is 5;

[0055] Step 3. The product parameters of the chromatographic column of the high performance liquid chromatograph are 150mm×4.6mm, 5μm C18 chromatographic column, the column temperature is set to 35°C, the detection wavelength is set to 210nm, the flow ...

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Abstract

The invention relates to a method for detecting N, N'-diacetyl-L-cystine in a compound amino acid injection by applying high performance liquid chromatography. The method comprises the following steps: preparing a mobile phase, preparing a reference substance solution, preparing a test solution, setting chromatographic instrument parameters, detecting the reference substance solution, detecting the test solution, and calculating the content of N, N'-diacetyl-L-cystine in the test solution. According to the method, a phosphate mobile phase system is adopted, separation of N, N'-diacetyl-L-cystine and adjacent chromatographic peaks can be achieved on a common C18 chromatographic column, operation is easy and convenient, the method is easy to implement, and compared with an ion pair mobile phase system, the method is good in reproducibility, does not need expensive ion pair reagents and is more economical.

Description

technical field [0001] The invention relates to a method for detecting the content of N,N'diacetyl-L-cystine in compound amino acid injection, especially a method for detecting N,N'- Method for diacetyl-L-cystine content. Background technique [0002] N,N'-diacetyl-L-cystine is the oxidative degradation impurity of N-acetylcysteine ​​in compound amino acid injection, monitoring the content of this impurity in compound amino acid injection can optimize process parameters and ensure product quality Provide evidence. In acetylcysteine ​​raw materials and acetylcysteine ​​single preparations (such as acetylcysteine ​​injection and acetylcysteine ​​inhalation preparations), quantitative detection methods for this impurity have been reported, and ion-pair chromatography is often used. Law. At present, there is no report on the detection method of N,N'-diacetyl-L-cystine in compound amino acid injection. Contents of the invention [0003] The purpose of the present invention ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8872
Inventor 徐大星张倩关凤吴方也
Owner 费森尤斯卡比华瑞制药有限公司
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