Method for detecting content of isomer impurities in sitafloxacin

A technology of sitafloxacin and impurity content, applied in the field of chemical analysis, can solve the problems of complex operation, expensive chromatographic column, poor reproducibility, etc., and achieve the effects of high sample recovery, accurate detection results, and strong practical value
CN107966489AInactive Publication Date: 2018-04-27SHANGHAI INST OF ORGANIC CHEMISTRY - CHINESE ACAD OF SCI
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
SHANGHAI INST OF ORGANIC CHEMISTRY - CHINESE ACAD OF SCI
Publication Date
2018-04-27
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention discloses a method for detecting the content of isomer impurities in sitafloxacin. The method comprises respectively preparing control solutions of isomers and sitafloxacin and a test sample solution, respectively detecting the control solutions and the test sample solution through a capillary electrophoresis method, and calculating contents of isomer impurities through an external standard method according to a peak area or a standard curve of the peak area and the concentration. The method has the advantages of low cost, simple processes, high resolution degree, good flexibility, good linearity, specificity, precision, stability, sensitivity, repeatability, high sample recovery rate and accurate and reliable detection result. The method realizes simultaneous separation of sitafloxacin and its isomers such as IMA, IMB, IMC, IMD and IME, provides an effective method for sitafloxacin product quality monitoring and has a practical value.
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Description

technical field

[0001] The invention relates to a method for detecting the content of isomer impurities in sitafloxacin, belonging to the technical field of chemical analysis. Background technique

[0002] It is well known in the art that the impurities in the drug are the main factors affecting the purity of the drug. If the impurities contained in the drug exceed the limit requirements specified in the quality standards, it is very likely to cause changes in the appearance, shape and physical and chemical parameters of the drug, and even affect the stability of the drug. , will lead to decreased drug activity and increased toxic and side effects, seriously endangering the product quality of the drug and the drug safety of patients; at the same time, the impurities in the drug cover a very wide range, not only including impurities with different molecular formulas in the conventional sense, but for chiral drugs , including impurities of drug isomers; more than 80% of the dr...

Claims

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