Quality control method of roxithromycin capsules
A quality control method, roxithromycin technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of long analysis and detection time, low detection efficiency, low precision, etc., to shorten the analysis time and improve the separation effect Good, short analysis time effect
Inactive Publication Date: 2014-05-07
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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Problems solved by technology
Generally adopt HPLC method to measure roxithromycin content in the prior art, but the measurement method of prior art, operation is more loaded down with trivial details, especially analysis time is longer, has higher requirement for the production enterprise of inspection time, and the common method of prior art The analysis and detection time of the HPLC method is long, and the precision is not high, the detection efficiency is not high, and it cannot meet the quality control of intermediate products that have high requirements for analysis time in the production process.
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[0027] The present invention is further illustrated below in conjunction with specific embodiments, should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention, after having read the present invention, those skilled in the art will understand the various equivalent forms of the present invention All modifications fall within the scope defined by the appended claims of this application.
[0028] The methodological investigation of the quality control method of Roxithromycin Capsules in Example 1
[0029] 1. Stability experiment
[0030] Take an appropriate amount of the content of roxithromycin capsules, grind it finely, accurately weigh an appropriate amount and place it in a measuring bottle, add acetonitrile with a volume ratio of 45:55 and ammonium dihydrogen phosphate solution with a concentration of 0.067mol / L, and oscillate ultrasonically for 20-30 minutes. Completely diss...
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Abstract
The invention discloses a quality control method of roxithromycin capsules. The method is used for detecting roxithromycin capsules by adopting ultra performance liquid chromatography. The optimal mobile phase composition, flow speed, detection wavelength, chromatographic columns and other analysis conditions are optimized by a plurality of experiments; repeated experiment verification shows that the quality control method of roxithromycin capsules, which is disclosed by the invention, is good in stability and repeatability, is rapid in analysis speed, is high in analysis efficiency, can detect the content of roxithromycin within 3 minutes, moreover is good in resolution, and can qualitatively and quantitatively detect target compounds flexibly and accurately, so that the quality of the roxithromycin capsules can be evaluated efficiently, objectively, comprehensively and accurately; the quality control method of roxithromycin capsules is of great significance in controlling the quality of the roxithromycin capsules and guaranteeing the clinical efficacy.
Description
technical field [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to a quality control method of roxithromycin capsules. Background technique [0002] The main ingredient of roxithromycin capsules is roxithromycin, 9-{O-[(2-methoxyethoxy)-methyl]-oximino} erythromycin, the molecular formula is C 41 h 76 N 2 O. Roxithromycin is a derivative of erythromycin A, a new generation of macrolide antibiotics, mainly acting on Gram-positive bacteria, anaerobic bacteria, chlamydia and mycoplasma. Generally adopt HPLC method to measure roxithromycin content in the prior art, but the measurement method of prior art, operation is more loaded down with trivial details, especially analysis time is longer, has higher requirement for the production enterprise of inspection time, and the common method of prior art The analysis and detection time of the HPLC method is long, and the precision is not high, the detection efficiency is not hi...
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IPC IPC(8): G01N30/88
Inventor 雷晓雪张高平王丽楠曹义海
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD