Simultaneous Determination and Pharmacokinetic Study of Danshensu and Protocatechuic Aldehyde of a Two-Step Release System of Compound Danshen in Dog Plasma by HPLC

摘要

A HPLC method using a UV detector for the simultaneous determination of Danshensu (DS) and Protocatechuic aldehyde (PA) released from a two-step release system (TSRS) of compound Danshen prepared by our laboratory in dogs was developed and validated. Chromatography was carried out using a C_(18) column at 35℃ with the mobile phase consisting of acetonitrile-monopotassium phosphate buffer (pH 2.8; 10 mM) (10:90, v/v), the detection wavelength was set at 281 nm. The calibration curves were linear over the range of 16.72-334.4 ng/mL for DS and 6.26-25.2 ng/mL for PA, respectively. At the concentrations of 18.6, 167.2, 836.0 ng/mL for DS and 6.96, 62.6, 313.0 ng/mL for PA, the corresponding mean recoveries were 58.7%, 63.5%, 67.7% and 88.1%, 91.1%, 93.3%, respectively. The limit of quantification was 16.72 ng/mL for DS and 6.26 ng/mL for PA, respectively. Overall, we reported and validated a method for the simultaneous determination of DS and PA released from the TSRS of compound Danshen in dogs by HPLC for the first time, and successfully applied it to the pharmacokinetic study of DS and PA in vivo after oral administration of the TSRS of compound Danshen to dogs.