Detection method for determining polymer impurities in mezlocillin sodium

A mezlocillin sodium and detection method technology, which is applied in the detection field of polymer impurities in mezlocillin sodium, can solve the problems of accurate qualitative and quantitative testing of impurities, long separation time, cumbersome operation, etc., and achieve accurate and fast qualitative Quantitative analysis, shortened separation time, and high resolution effects
CN103063751AInactive Publication Date: 2013-04-24SEPAX TECH
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
SEPAX TECH
Publication Date
2013-04-24
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a detection method for determining polymer impurities in mezlocillin sodium. The detection method employs a high performance liquid chromatography size exclusion chromatography. The chromatography conditions are as follows: a chromatographic column employs hydrophilic silica for globular protein as a stationary phase and 50 mmol of a phosphate buffered solution as a mobile phase; a flow velocity of the mobile phase is 0.5-2.0 mL / min; a detection wavelength is 230-254 nm; a column temperature is a room temperature; a sample volume is 10-80 [mu]L; granularity of the chromatographic column stationary phase is 5 [mu]m, aperture of the chromatographic column stationary phase is 10 nm; the inner diameter of the chromatographic column is 7.8 mm; and the column length is 300 mm. he detection method can perform rapidly qualitative and quantitative determination on the polymer impurities in mezlocillin sodium, simultaneously simplifies operation steps, increases detection precision and shortens detection time.
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Description

technical field

[0001] The invention relates to the field of size exclusion detection, in particular to a detection method for measuring polymer impurities in mezlocillin sodium. Background technique

[0002] Mezlocillin sodium is a semi-synthetic penicillin antibiotic, which has a strong antibacterial effect on Gram-positive bacteria such as Escherichia coli, Enterobacter, and Proteus. Mezlocillin is a penicillin derivative administered parenterally and has bactericidal effect in large doses. The antibacterial spectrum of mezlocillin sodium is basically the same as that of ampicillin and carbenicillin. However, there are some polymer allergic impurities in mezlocillin sodium. Therefore, it is necessary to control the total amount of high molecular impurities in the quality standard of the drug.

[0003] At present, the 2010 edition of "Chinese Pharmacopoeia" uses medium and low pressure liquid chromatography detection method for the detection of polymer impurities in me...

Claims

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