Simultaneous Determination of Components in Preparation Naodesheng Injection by High Performance Liquid Chromatograph-Atmospheric Pressure Chemical Ionization Mass Spectrometry (HPLC-MS/APCI)

概要

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A high-performance liquid chromatograph with mass spectrum detection (HPLC-MS/APCI) method has been established for simultaneous determination of ten major bioactive components of Naodesheng injection including safflor yellow A, puerarin, daidzein, ginsenosides (Rg_1, Rg_2, Rb_1, Rd, Re, Rh_1), and notoginsenoside R_1. The separations were carried out with a Luna C_<18> column (5μm, 150×4.6mm, Phenomenex, U.S.A.) with a stepwise gradient elution of the mobile phase consisting of water (0.1% of formic acid, v/v)-methanol (0min, 70:30; 8min, 30:70; 20min, 10:90) at a flow-rate of 0.8ml/min. The proposed method was applied to analyze five various Naodesheng injections and produced data with acceptable linearity, repeatability, precision and accuracy having lower limits of quantitation (LLOQs) of 0.02-0.2μg. The calibration curves were linear in respective range for all compounds, all of them with coefficients of determination above 0.9900. The intraday precessions were less than 5.0%. The proposed method is accurate, sensitive and simple, a useful alternative for routine analysis in the quality control of Traditional Chinese Medicine.
公益社団法人日本薬学会の論文
2006-04-01