Study on fingerprint of Leech Lyophilized Injection
AIM: To establish fingerprint of Leech Lyophilized Injection for quality control. METHODS: According to the evaluating system 2004A issued by State food and drug administration (SFDA) and appendix of Pharmacopoeia of People's Republic of China I, we filtered the Conditions as chromatographic column, mobile phase, determination wavelength, testing solution preparing and test the fingerprint of 10 patches of Leech Lyophilized Injection. RESULTS: ① The high performance liquid chromatography (HPLC) method was set up using Kromasil KR100-5C18(250 mm x 4.6 mm,5μm) column with mobile phase of water-methanol-tetra hydrofuran( 100:0. l:0. 05) ,and determination wavelength was 249 nm. In the recorded chromatogram of the test preparation, Relative Standard Deviation ( RSD) of the relative retention time and the relative peak areas of all peaks compared with hypoxanthine peak were measured. The similarity of 10 patches of Leech Lyophilized Injection was appraised by the similarity evaluation system. ②In this chromatogram condition,5 peaks were identified as the characteristic fingerprint of Leech Lyophilized Injection. ③The retention time for hypoxanthine in Leech Lyophilized Injection were consistent with each other. RSD(%) of the relative retention time and the relative peak areas of all peaks compared with hypoxanthine peak fit the requirements of fingerprint. The chromatography showed good similarity up to 92% in 10 patches of I>eech Lyophilized Injection. CONCLUSION: The HPLC method of testing fingerprint of Leech Lyophilized Injection is exact,simple and accurate,and can be used for quality control of Leech Lyophilized Injection.
NETL
NSTL
万方数据
维普
