Standard Study On High Performance Liquid Chromatography Of Tetracycline Tablets

Tetracycline is relatively stable at room temperature to avoid light,but it is prone to deterioration in environments with strong temperature,humidity,or light,and tetracycline side effects are many and serious,such as bone deformity,liver and kidney damage,etc..In 1963,it was found that the use of Metamorphic tetracycline preparations(containing dehydrated tetracycline and dehydrated tetracycline impurities)could cause Fankangni syndrome.Therefore,how to identify tetracycline and detect tetracycline content stably and quickly in drug detection is a research topic.Tetracycline testing is mainly aimed at six test items:drug traits,chemical identification,thin layer identification,weight difference inspection,disintegration time limit inspection and content determination.In the Ministry of Health's drug standard(the first volume of antibiotics),the method of content determination is defined as the biological valency method.This method is cumbersome in operation,has many influencing factors,and the detection time is too long.At the same time,the method of identification of tetracycline in the Ministry of Health's drug standard(the first volume of antibiotics)is complex.There are many influencing factors and poor specificity.The main work of this paper includes the establishment of high performance liquid chromatography for the determination of tetracycline in drugs.The mobile phase is:ammonium acetate solution(ammonium acetate solution:0.15mol/L ammonium acetate solution-0.01mol/L ethylenediaminetetraacetic acid disodium solution-triethylamine(100:10:1)with acetic acid to adjust the pH to 8.5-Acetonitrile(83:17),solution:0.01 mol/L hydrochloric acid solution,flow rate:1.0mL/min,detection wavelength:280 nm;injection amount:10?L.The liquid chromatographic identification method is used as a special identification method,and the related substance inspection method is added.After research,the detection method has the advantages of high reproducibility,low detection cost and fast analysis,and has high linearity and small standard deviation.The detection limit is also lower than the biopotency method in the Chinese Pharmacopoeia,which aims to be closer to the true and more comprehensive detection of the quality of tetracycline tablets.It can be used for routine testing of tetracycline tablets.