Impurity analysis and preparation method for clindamycin phosphate

Abstract

The invention provides an impurity analysis and preparation method for clindamycin phosphate, which is used for analyzing a clindamycin phosphate raw material and separating and preparing impurities from the clindamycin phosphate raw material. The method comprises the following steps of: measuring the clindamycin phosphate raw material by using liquid chromatography-mass spectrometry (LC-MS), and determining one or more impurities in the raw material according to the relative retention time and / or molecular weight of each analyzed component; and determining the conditions of preparative chromatography according to chromatographic retention behaviors displayed by the relative retention time of each impurity, and collecting the one or more impurities corresponding to the relative retention time and / or molecular weights by using the preparative chromatography.

Description

technical field [0001] The present invention relates to the field of analytical chemistry, in particular to the field of pharmaceutical analytical chemistry, in particular to the impurity analysis and preparation method of clindamycin phosphate. Background technique [0002] Clindamycin phosphate has no antibacterial activity in vitro. After entering the body, it is rapidly hydrolyzed into clindamycin under the action of phosphatase, and converted into N-desmethyl clindamycin with strong antibacterial activity in vivo. It acts on the 50S subunit of bacterial ribosomes, thereby preventing the elongation of peptide chains and interfering with the synthesis of bacterial DNA and bacterial proteins. It can still remove protein A and fluffy coats on the surface of bacteria, making bacteria easy to be swallowed and killed. Clindamycin phosphate mainly has strong antibacterial activity against Gram-positive cocci and anaerobic bacteria. Its effect and use are similar to that of clin...

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Problems solved by technology

[0006] 2. Reaction raw materials that exist due to incomplete reaction, reaction initial complexes, synthetic intermediate products, by-products and other substances related to the synthesis process;

[0022] 5. In addition to degradation products and toxic impurities, the impurities that have been controlled in the raw materials are generally no longer controlled in the preparation;

From the analysis of new drug declarations in recent years, there are many problems in the research and limit determination of impurities, mainly as follows: some drug research units do not have a deep understanding of the importance of impurity research; the control of impurities in standards is not enough Comprehensive and accurate; considerations are not comprehensive when formulating impurity limits, and the adverse effects of impurities on drug safety are rarely considered; even when the content of impurities is obviously beyond the range allowed by normal processes, no attention is paid to the current prescription and process. Necessary optimization to reduce impurity limit

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