Original Articles
Bai Jing
Abstract
The purpose of the present work was to develop and validate a reliable and effective method for the analysis of Shengmai injection and its raw materials by reverse phase high pressure liquid chromatography. The Kromasil C18 column (5 μm, 4.6 mm × 250 mm)was used. Water containing 0.01% phosphoric acid and acetonitrile were used as mobile phases with gradient elution. The detection wavelengths was monitored at 203nm. The flow rate was set at 1.0 mL/min and column temperature was 35°C. ginsenosides Rg1, Re, Rb1 and schizandrin were used as marker compounds and determined for the quality control in productive process. On the basement of method validation, 5 samples of Shengmai injection and 3 batchs of raw materials were monitored for the quality control. The analytical method has suitable levels of precision, reproducibility, stability and linearity , which could be used as a new method for the quality control of Shengmai.