Method for detecting element impurities in tigecycline for injection

A detection method and tigecycline technology, which are applied in the preparation of test samples, measuring devices, sampling, etc., can solve the problems of complex detection methods for element impurities

Inactive Publication Date: 2020-04-24
瀚晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The main purpose of the present invention is to provide a method for detecting elemental impurities in tigecycline for injection, to solve the problem of complicated detection methods for elemental impurities in tigecycline in the prior art

Method used

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  • Method for detecting element impurities in tigecycline for injection
  • Method for detecting element impurities in tigecycline for injection
  • Method for detecting element impurities in tigecycline for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Prepare linear standard solutions

[0052] Prepare standard solutions of each element with a concentration of 1000 μg / mL; mix 100 μL cadmium standard solution, 250 μL cobalt standard solution, 150 μL mercury standard solution and 250 μL lead standard solution and dilute to 10 mL with diluent to obtain linear stock solution A; Mix 1.0mL linear stock solution A, 75μL arsenic standard solution, 50μL vanadium standard solution, 50μL palladium standard solution, 100μL nickel standard solution, 1.0mL calcium standard solution, 2.5mL silicon standard solution, 200μL copper standard solution, lithium standard solution, Antimony standard solution, aluminum standard solution, boron standard solution, barium standard solution, chromium standard solution, iron standard solution, magnesium standard solution, manganese standard solution, molybdenum standard solution and zinc standard solution were mixed and dilute to 25mL with diluent to obtain Linear stock solution B; dilute linea...

Embodiment 2

[0078] The difference from Example 1 is that the diluent consists of HNO 3 : Purified water: gold Au standard solution = 1:99:0.02 (v / v / v).

[0079] Since there are many elements detected in this application, the linear regression equation corresponding to the standard curve of each element is listed in Table 4, and the concentration value is calculated according to the linear regression equation and the detected response value intensity, and the concentration value is converted according to the aforementioned formula. The content of corresponding elements in tigecycline for injection is recorded in Table 4.

[0080] Table 4

[0081]

[0082]

Embodiment 3

[0084] The difference from Example 1 is that the diluent consists of HNO 3 : Purified water: gold Au standard solution = 3:97:0.02 (v / v / v).

[0085] The formula corresponding to the standard curve of each element is shown in Table 5.

[0086] table 5

[0087]

[0088]

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Abstract

The invention provides a method for detecting element impurities in tigecycline for injection. The detection method comprises the following steps: preparing a linear standard solution of each elementimpurity; preparing an internal standard solution; preparing a sample to be detected, redissolving tigecycline for injection with purified water to form an aqueous solution, and mixing the aqueous solution with a diluent to form a to-be-detected sample, wherein the diluent is a mixed solution of HNO3, purified water and a gold standard solution in a volume ratio of (1-3): (97-99): 0.02, and the concentration of the gold standard solution is 1000 [mu] g/mL; drawing a standard curve; sample detection: mixing the to-be-detected sample and the internal standard solution, introducing the sample anddetecting by using an inductively coupled plasma mass spectrometer to obtain the response values of each element; and converting to obtain the impurities of each element in tigecycline for injectionaccording to the response value obtained by sample detection and the standard curve. The diluent ensures the dissolution performance of the element impurities so that the content of the impurities ofeach element can be detected by one method.

Description

technical field [0001] The invention relates to the technical field of tigecycline quality detection, in particular to a method for detecting elemental impurities in tigecycline for injection. Background technique [0002] Tigecycline (TigecycLine), developed by the Wyeth Pharmaceutical Company of the United States, is a new type of broad-spectrum active intravenous antibiotics. It is also active against drug-resistant methicillin-resistant Staphylococcus aureus. It is a glycylcycline class The first drug in , has the following chemical structure: [0003] [0004] When synthesizing tigecycline, the raw materials used, such as catalysts, etc. contain heavy metals, which are difficult to separate from the product during purification, resulting in tigecycline containing some inorganic element impurities. In the process of preparation production, auxiliary materials and contact with production pipelines may also introduce inorganic elements. In addition, there may also be ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N27/62G01N1/38G01N27/626
CPCG01N27/62G01N1/38G01N2001/386
Inventor 杜加秋徐慧娟李泽南王妙新赵技宇
Owner 瀚晖制药有限公司
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