Raw chlorogenic acid or drug substance chlorogenic acid and its preparation method and mass detection method

摘要

Provided is a chlorogenic acid raw material or active pharmaceutical ingredient, containing chlorogenic acid having a weight percentage content of more than 98% and impurities having a weight percentage content of less than 1.9%. The impurities contain 3-coumaroylquinic acid, accounting for 0.1-0.5% of the total weight of the raw material or active pharmaceutical ingredient. Also provided is a preparation method for the chlorogenic acid raw material or active pharmaceutical ingredient, and a quality testing method. In the preparation method for the chlorogenic acid raw material or active pharmaceutical ingredient, after crystallisation, it is not necessary to undergo re-crystallisation process treatment, thereby reducing chlorogenic acid loss caused by re-crystallisation, and increasing product yield. At the same time, reduction of a re-crystallisation process shortens the production cycle, and applicability is strong, facilitating large-scale preparation of chlorogenic acid. Product quality controllability is strong, relevant impurities are all within a controlled range, and a relevant impurity having a content of more than 0.1% can be qualitatively and quantitatively analysed. The testing method has a high testing sensitivity for chlorogenic acid and analogues thereof. A mobile phase does not significantly interfere with related substance testing, the number of plates is high, the degree of separation is good, and peak symmetry is good.