Simultaneous determination of four active components in Shengmai injection and its application to the quality control in productive process
نویسنده
چکیده
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.
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