Research On The Chromatographic Fingerprint Of Gan Xintai Injection

Aim:The chromatographic fingerprint of Gan Xintai Injection and method of determination of Leu in Gan Xintai Injetion was developed by RP- HPLC to control the quality of Gin Xintai jection.Methods:A method for the HPLC fingerprint of Gan Xintai injection by high performance liquid chromatography with gradient HPLC.Column:Kromasil C18(5μm,4.6×250mm) The mobile phase A was acetoneitrile;The mobile phase B was N,N-dimethylfor mamide(DMF)-0.025mol/L natrium aceticum(1:100,adjust pH to 3 with acetic acid),0-60 min(A:10%-43%;B:90%-57%);wavelength was 360nm;Flow rate was 1mL/min;Column temperature was 25℃.The method of determination of Leu was developed for control the quality of in Gan Xintai Injetion.Column:DaLian Yilite ODS-C₁₈(4.6mm×250mm,5μm);Mobile phase: acetoneitrile-N,N-dimethylfor-mamide-0.025mol/L natrium aceticum(26:1:73)(adjust pH to 3 with acetic acid),Wavelength:360nm;Flow rate:1mL/min;The liner range was 0.0744～0.4464mg/ml(r= 0.9997,n=6).The average recoveries were 99.14%, RSD=0.97%(n=6).Results and Conclusion:A method for the HPLC fingerprints of Gan Xintai injection by high performance liquidchromatography with UV detection at 360 nm is described.8 peaks in the HPLCfingerprints of Gan Xintai injection were separated using gradient HPLC. The column to be used was Kromasil C18(5μm,4.6×250mm).Total chemical data were obtained.The similarities were deterniined by the soft ware of similarty analysis.As result The 9 batchs of Gan Xintai injections of similarity were 0.90～1.00.It can conclude that the quality of Gan Xintai injetions are stationary.The chromatographic fingerprints for the quality control of Gan Xintai injection have been established in this study.In conclusion,more powerful technical supports for Gan Xintai injection in safety,effectiveness,stability and control will be provided.The method should be helpful explore as a new quality control method for Traditional Chinese Medicine.At the same time,it will be a model for other studies on the fingerprinting standardization of TCM Injections.