Cysteine hydrochloride in acetaminophen injection and test method of degradation product cystine

A technology of cysteine ​​hydrochloride and acetaminophen, which is applied in the field of determination of cysteine ​​hydrochloride and the degradation product cystine, achieves the effects of simple operation, good separation and accuracy, and strong specificity

Inactive Publication Date: 2015-12-23
NANJING TIANXIANG PHARMA TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] In order to solve the problem of the analysis method of cysteine ​​hydrochloride and the degradation product cystine in acetaminophen injection, the inventor explored the quality control method of the preparation through a large number of experiments, and finally used the phosphate buffer containing ion pair Cysteine ​​hydrochloride and impurities were successfully separated by gradient elution method, and the method was strictly verified to ensure the scientific rigor of the method and meet the needs of R&D and production.

Method used

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  • Cysteine hydrochloride in acetaminophen injection and test method of degradation product cystine
  • Cysteine hydrochloride in acetaminophen injection and test method of degradation product cystine
  • Cysteine hydrochloride in acetaminophen injection and test method of degradation product cystine

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Embodiment 1

[0037] Embodiment 1, the development of the analysis method of cysteine ​​hydrochloride and degradation product cystine

[0038] In order to control the quality of the product, the antioxidant content is a relatively important index in the injection. There are many standards and methods in the literature for the detection of the content of cysteine ​​hydrochloride, but for the cysteine ​​hydrochloride in acetaminophen injection The detection of cystine and its degradation product cystine is not applicable. In this regard, we have launched the research and exploration of the detection method of cysteine ​​hydrochloride and its degradation product cystine in injection.

[0039] The detection methods of cysteine ​​hydrochloride include titration method, UV method and HPLC method, etc. We use HPLC method to establish the detection method of cysteine ​​hydrochloride and the degradation product cystine in this product.

[0040] Chromatographic conditions: Agilent1100 series HPLC ins...

Embodiment 2

[0051] Example 2, Verification of the analytical method of cysteine ​​hydrochloride and degradation product cystine

[0052] The specificity of the above-mentioned methods to be selected was investigated, and the following tests were carried out according to the guidelines for the verification of pharmaceutical quality standards for analytical methods: (1) Acid destruction: take 0.25mg / ml of cysteine ​​hydrochloride and 10ml of the sample respectively, add 1mol / ml L hydrochloric acid solution 2ml, at room temperature for 2h. (2) Alkali destruction: Take 0.25mg / ml cysteine ​​hydrochloride and 10ml sample respectively, add 2ml 1mol / L sodium hydroxide solution, and place at room temperature for 2h. (3) Oxidative damage: Take 0.25 mg / ml of cysteine ​​hydrochloride and 10 ml of sample respectively, add 2 ml of 30% hydrogen peroxide. (4) High-temperature destruction: Take 0.25 mg / ml of cysteine ​​hydrochloride and 10 ml of sample respectively, and place them at 80°C for 4 hours. (...

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Abstract

The invention discloses cysteine hydrochloride in acetaminophen injection and a test method of degradation product cystine. The method adopts efficient liquid chromatography, a flowing phase adopts a phosphate buffer containing ion pairs and an organic solvent, and a gradient evaluation method is adopted. The method can be used for testing the content of cysteine hydrochloride in the acetaminophen injection, controlling the content of the content of cysteine degradation product cystine and testing the content of cysteine hydrochloride raw materials, the cysteine and the cystine have good resolution, the specificity and the sensitivity are high, and the operation is simple and convenient.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to an analysis method for acetaminophen injection, in particular to a method for measuring cysteine ​​hydrochloride and degradation product cystine in acetaminophen injection. Background technique [0002] Acetaminophen is used for fever, and can also be used to relieve mild to moderate pain, such as headache, muscle pain, joint pain, neuralgia, dysmenorrhea, cancer pain, and postoperative pain relief. This product can be used for patients who are allergic or intolerant to aspirin. [0003] Cysteine ​​hydrochloride is used as an antioxidant in the prescription of acetaminophen injection. Cysteine ​​hydrochloride has low toxicity, is not easy to change color, and has a certain solubilizing effect, which can improve the color and clarity of the solution. However, cysteine ​​hydrochloride is easily oxidized to generate cystine, an oxidative degradation impurity, and the content of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/34
Inventor 胡长花张爱琴李正海赵国新潘娜娜
Owner NANJING TIANXIANG PHARMA TECH
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