Content determation method for 12-dehydroxylation Azierythromycin and preparation thereof
A technology for the determination of hydroxyazithromycin and its method is applied in the field of content determination of 12-dehydroxyazithromycin and its preparations, which can solve the problems that there is no ideal method for determination, and achieve high accuracy and robustness. Good practicality and reproducibility
Inactive Publication Date: 2005-05-18
姜建国
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[0004] Molecular formula C 38 h 72 N 2 o 11 , with a molecular weight of 732.99, is a broad-spectrum antibacterial drug. It has good antibacterial activity against most Gram-negative bacteria and intracellular pathogens, mycoplasma and chlamydia, and has certain antibacterial activity against Gram-positive bacteria. There has been no ideal method for the content of drugs and their preparations
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[0010] The content determination method of 12-dehydroxyazithromycin and preparation thereof, its structural formula is
[0011]
[0012] Determination method is as follows: adopt high performance liquid chromatography and ultraviolet detector, with C 18 Alkali-resistant chromatographic column, methanol-water or phosphate buffer as the mobile phase as the chromatographic condition, the pH of methanol-water or phosphate buffer is 9.5, use the mobile phase to make 30mg of 12-dehydroxyazithromycin / ml solution, inject 15ul with a microsampler to detect the content of 12-dehydroxyazithromycin and its preparations.
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The invention discloses a method for determining the content of 12-dehydroxyazithromycin and its preparations. 18 Alkali-resistant chromatographic column, methanol-water or phosphate buffer as the mobile phase as the chromatographic condition, the pH value of methanol-water or phosphate buffer is 7 to 11, and the mobile phase is prepared by 12-dehydroxy azithromycin into a solution of 20-35mg / ml, inject 15ul with a microsampler, and then detect the content of 12-dehydroxyazithromycin and its preparations. The invention uses high-performance liquid chromatography to measure the content of the medicine and its preparation, which is simple, rapid, high in accuracy and good in reproducibility, and has strong practicability in the production and quality control of the medicine and its preparation.
Description
technical field [0001] The invention relates to a content determination method of 12-dehydroxyazithromycin and its preparation. Background technique [0002] 12-Deshydroxyazithromycin and its preparations are a new type of antibiotic drug, and its structural formula is [0003] [0004] Molecular formula C 38 h 72 N 2 o 11 , with a molecular weight of 732.99, is a broad-spectrum antibacterial drug. It has good antibacterial activity against most Gram-negative bacteria and intracellular pathogens, mycoplasma and chlamydia, and has certain antibacterial activity against Gram-positive bacteria. There is no ideal method for the content of medicines and preparations thereof. Contents of the invention [0005] In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a simple, rapid, accurate, reproducible method for the determination of the content of 12-dehydroxyazithromycin and its preparations. [0006] The technica...
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IPC IPC(8): G01N30/02G01N30/36G01N30/40G01N30/74
Inventor 姜建国张西如杨梁胡孟魁
Owner 姜建国