An ultra-performance liquid chromatography (UPLC) method with diode array detection was developed for simultaneous analysis of eight ginsenosides (ginsenosides Rg(1), Re, Rf, Rb-1, Rc, Rb-2, Rb-3, Rd) and one lignan (schizandrin) in Sheng-mai injection, a traditional Chinese medicine prescription widely used for the treatment of cardiovascular diseases. The chromatographic separation was performed on a Waters ACQUITY UPLC(R) HSS 13 column (1.8 mu m, 100 mm x 2.1 mm i.d.) using a linear gradient elution over 28 min with a mixture of water and acetonitrile as the mobile phase. All calibration curves showed good linearity (r(2) > 0.9998) within the test ranges. Validation proved the repeatability of the method was good and recovery was satisfactory. The validated method was successfully applied to 12 batches of Sheng-mai injection. The results showed that there was a great variation among different samples. Principal component analysis (PCA) further proved considerable variations among the samples from different factories and suggested that schizandrin, ginsenosides Rb-1 and Rg(1) might have the greatest influence on the variation of 12 samples. In conclusion, these results demonstrated that the UPLC method proposed was very useful for the analysis and quality evaluation of Sheng-mai injection.
[1]Natl Inst Food & Drug Control, Beijing 100050, Peoples R China.
[2]Beijing Univ Chinese Med, Sch Chinese Mat Med, Beijing, Peoples R China.
[3]Shanghai Univ Tradit Chinese Med, Inst Chinese Mat Med, Shanghai, Peoples R China.
(8.0+极速模式)