Simultaneous determination of components in preparation Naodesheng injection by high performance liquid chromatograph-atmospheric pressure chemical ionization mass spectrometry (HPLC-MS/APCI).

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 (Rg1, Rg2, Rb1, Rd, Re, Rh1), and notoginsenoside R1. The separations were carried out with a Luna C18 column (5 microm, 150x4.6 mm, Phenomenex, U.S.A.) with a stepwise gradient elution of the mobile phase consisting of water (0.1% of formic acid, v/v)-methanol (0 min, 70:30; 8 min, 30:70; 20 min, 10:90) at a flow-rate of 0.8 ml/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 0.02-0.2 microg. 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.