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Chiral stationary-phase detection method for dextroisomer of pazufloxacin mesilate injection

A technology of pazufloxacin mesylate and chiral stationary phase, which is applied in the field of chiral stationary phase detection of the dextrorotatory isomer of pazufloxacin mesylate injection, and can solve problems such as cumbersome operation

Active Publication Date: 2014-01-01
CHENGDU BAIYU PHARMA CO LTD
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Problems solved by technology

The indirect method (CDR) involves pre-column derivatization of enantiomers into diastereoisomers, requiring chiral derivatization reagents of high optical purity, and the operation is cumbersome

Method used

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  • Chiral stationary-phase detection method for dextroisomer of pazufloxacin mesilate injection
  • Chiral stationary-phase detection method for dextroisomer of pazufloxacin mesilate injection
  • Chiral stationary-phase detection method for dextroisomer of pazufloxacin mesilate injection

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Embodiment Construction

[0035] The following describes but does not limit the present invention through the description of specific embodiments of the present invention.

[0036] The existing technology is: document "Chiral Separation of New Drug Pazufloxacin Mesylate" (Shanghai Pharmaceutical Industry Research Institute, Li Xiaoning, Zhang Minru, Shi Xiang), chiral stationary phase chromatographic column method for separation of Pazufloxacin Mesylate The conditions for the Floxacin enantiomers are described as follows:

[0037] Take an appropriate amount of pazufloxacin mesylate, dissolve it with 0.1% trifluoroacetic acid in absolute ethanol, make a test solution of about 1 mg / ml, and inject 20 μl of it.

[0038] The chromatographic conditions used here are Chiralpak AD-H, 250mm×4.6mm, 5μm (DAICEL, Japan), followed by a pre-column, the same as the analytical column, 30mm long, mobile phase: 0.1% trifluoroacetic acid isopropanol- n-hexane (10:90); column temperature: 20°C, flow rate: 1.0ml / min, dete...

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Abstract

The invention belongs to the field of medicine analysis, and particularly relates to a chiral stationary-phase detection method for the dextroisomer of pazufloxacin mesilate injection. The invention aims at providing a method which is simple and convenient to operate, and capable of rapidly and accurately detecting a dextroisomer, wherein HPLC (high performance liquid chromatography) detection conditions are as follows: 5mu m silica gel coated with amylose-tri(3,5-dimethylphenyl carbamate) on the surface or 5mu m silica gel coated with amylose-tri[(S)-alpha-methylphenyl carbamate] on the surface is used as a filler in a stationary phase; a mobile phase A is a phosphate buffered solution; a mobile phase B is acetonitrile or ethanol, wherein the phosphate buffered solution contains 10-100 mM of monopotassium phosphate; the pH value is adjusted to 1.5-4.0 by phosphoric acid; a mobile phase is prepared from the mobile phase A and the mobile phase B in a volume ratio of (50 to 90): (50 to 10); a flow speed is 1.0 ml / min; a column temperature is 10-25 DEG C; a detection wavelength is 240 nm; and the number of theoretical plates is not less than 2500 counted by the peaks of the laevoisomer of pazufloxacin, and a separation degree between the laevoisomer and the dextroisomer of pazufloxacin needs to meet requirements.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a chiral stationary phase detection method for the dextro-isomer of pazufloxacin mesylate injection. technical background [0002] Quinolones are antibacterial drugs that have developed rapidly in recent years. The average annual growth rate of quinolones in the world is 8% to 10%, and the sales volume reaches more than 8 billion US dollars. According to the statistics of 14 domestic cities, anti-infective drugs accounted for 29.54% of the total drug purchases, among which quinolones accounted for 14.89% of the total anti-infective drugs, ranking third. Moreover, the top two cephalosporins and penicillins show a clear downward trend, while quinolones show a strong upward trend, approaching the share of penicillins. Pazufloxacin mesylate is a fourth-generation quinolone drug, which has been widely used in the clinical treatment of various bacterial infections and has achieved good cl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 孙毅田阿娟乔阳何捷
Owner CHENGDU BAIYU PHARMA CO LTD
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