Preparation And Fixed Value Of Main Components Of Chinese Medicinal Reference Materials

Objective To obtain the content was up to 99.5% of the enough standard sample(we will make another adjustment for the difficult one),we purified the Kempferol(the initial purity was 98.71%)、Naringenin(the initial purity was 98.64%)、Chlorogenic acid to(the initial purity was 96.56%).At the same time,we build the method of assay of Naringenin by HPLC.Methods we mainly adopted the recrystallization to purify the above of the four effective constituents.The method count the assay of the three samples by area normalization method.The result of radionuclide certification are described to:Standard value±The source of the uncertainty.The method used HPLC to definite value when the stability and uniformity of the standard materials were both qualified.The statistics was used for the calulate method of the the source of the uncertainty.Results The assay of the Kempferol was 99.76%,the Naringenin was 99.83 and the Chlorogenic acid was 99.27%.The method of the fixed value of the Naringenin was reliable.The final purity of the Naringenin as show:99.635%±0.408%,k=2,P=0.95.Conclusion The study supply the standard materials for being researched and applied for the above of the qualification control of the active constituents.The traditional chinese medicine quality may traceability contact to the international measurement of the traceability will come be true. Objective To establish a HPLC method for determination of Escitalop -ram Oxalate and its related substances,then study on the dissolution of tablets. Methods A HPLC method was selected.The column:Inertsil C8(250×4.6 mm, 5μm);The mobile phase:Acetonitrile- Buffer(In a volumetric flask,dissolve about 1 g of sodium acetate in 800 ml of water,and add 6 ml of triethylamine.Adjust to pH 4.6 with acetic acid,and dilute with water to volume of 1 L)(30:70);Detection wavelength: 239 nm;The flow rate: 1.0 ml/min;The column tempture:40℃.Main component self-compare with calibration factor was used when testing impurity content.To establish a method for dissolution of tablet by Ultraviolet spectroscopy,the dissolvent was 0.1 mol/L diluted hydrochloric acid,the RPM was 50.Results The linear range of Escitalopram Oxalate was 5～800μg/ml,r=0.9999;The LOD was 0.94 ng;The LOQ was 3.12ng;The result of the dissolution was 98.3%,97.4%,96.4%.There was no difference in the self-made and import of ESC by comparing the curve of dissolution.Conclusion The methods are simple,accurate and sensitive , and can control the quality of the preparation effectively.