Studies And Applications On The HPLC Conditions Of The Assay And Fingerprint Of Notoginsenosides

Notoginsenosides Series Injections are made from notoginsenosides extracted from Radix notoginseng. Notoginsenosides Series Injections can produce good social and economical benefits due to their special strongpoints such as clear biological-active components, confirmed clinical curative effects, few adverse reactions, controllable quality and high technical contents.However, there are some obstacles on protecting their production and market due to the laggard quality analysis methods of current legal quality standard and we hereby research the Notoginsenosides Series Injections assay and fingerprint in order to provide the reference of upgrade of the legal quality standard of Notoginsenosides Series Injections.Although it's one of the hot topic of assay and fingerprint of notoginsenosides with HPLC method, the application of its legal quality standard faces to the following difficulties:· Main components separated difficultly — ginsenoside Rg₁ and ginsenoside Re are overlayed completely or separated partly under most common HPLC conditions which induces the HPLC fingerprint informations losed in part and the assay of the above two components inaccurate;· HPLC with gradient profile reproduced badly— the developed order of ginsenoside Rb₁ and its neighbor peaks is uncertain which results in the HPLC fingerprint uncertain and the assay of ginsenoside Rbj inaccurate;· Analyse result influenced by personal factor - Manual matching has to be done during samples' HPLC being matched with the standard HPLC produced previously when the peaks' retain times in HPLC of notoginsenosides are not reproducibility especially non-linear shift such as fingerprint peaks overlapping or the retain order being upside down due to the changes of gradient profile or column temperature or different band C-18 columns or HPLC instrument, thus the result could be uncertains;· The increase of the analysis cost — in order to improve the quality evaluation of notoginsenosides, the assay components numbers should be added and it will cause the increase of analysis cost, thus the enterprises and quality supervisor departments could not sustained for a long term and the increased analysis cost will be transferred to the consumers in the end.