Impurity detection method of clarithromycin

Abstract

The invention provides an impurity detection method of clarithromycin. The method specifically comprises the following steps: preparing a crude drug test solution; preparing an evaluation solution; preparing a self-control solution; preparing a system sensitivity evaluation solution; preparing a system suitability solution; preparing a blank solvent; successively introducing samples and requiring that ratio of impurity D's peak height / principal component peak to impurity D's adjacent peak valley in the atlas is not less than 3.0; and finding out impurity position and peak area in the test object atlas referring to the system suitability atlas, and calculating contents of various impurities by a self-contrasted method so as to finish the detection. By the method, load of system and chromatographic column is reduced, impurity determination level is improved, and an ideal determination effect is achieved through system adjustment.

Description

technical field [0001] The invention provides a method for detecting impurities in a clarithromycin crude drug, which belongs to the category of analysis methods. Background technique [0002] Clarithromycin is a derivative of erythromycin, successfully developed by Japan's Taisho Company in the early 1990s, and registered under the trade name Clarith. Afterwards, Dazheng Company first transferred its technology to Abbott of the United States for production; it was launched in Ireland and Italy in 1990, and was approved by the FDA in October 1991 as a Class IB new drug. The trade name in Europe and Asia is called Clarixin, and it has been launched in more than 50 countries around the world. The market usage has grown steadily and it has played an important role in clinical practice. Clarithromycin and its tablets, currently produced dosage forms also include granules, dispersible tablets, sustained-release tablets, injections and dry suspensions. [0003] It is mainly used...

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Problems solved by technology

[0011] After the above comparison, the company decided to aim at USP (API) standards, improve the standards of the company's products, improve product quality, and purchase system applicability reference substances for international standard impurity positioning, and the standard map of the standard report (see figure 1 ), the system applicability reference substance of international standard impurity positioning was tested under the system of the determination method of related substances in the standards contained in the "Chinese Pharmacopoeia", and the results showed that the current determination system contained in the Chinese Pharmacopoeia could not distinguish foreign standards Impurity localization requirements, see figure 2

[0012] Graphs 1 and 2 clearly show that the system suitability reference substance for international standard impurity positioning is very different from the graphs obtained by operating under the system recorded in Chinese Pharmacopoeia standards, and the impurities cannot be assigned and the impurities cannot be separated, indicating that this assay method Chromatographic conditions to detect clarithromycin products comparable to international standards are not suitable

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