A combined HPLC-PDA and HPLC-MS method for quantitative and qualitative analysis of 10 major constituents in the traditional Chinese medicine Zuo Gui Wan

A method using a high-performance liquid chromatograph coupled with a photodiode array UV detector (HPLC-DAD) and an electrospray ionization mass spectrometer (HPLC-ESI/MS) was developed for the quality assessment (fingerprinting and simultaneous quantification of 10 major constituents) of Zuo Gui Wan (ZGW), a Traditional Chinese Medicine (TCM). The compounds were identified on the basis of comparison of their mass spectra with literature data and standard samples and quantified by the HPLC-DAD method. Baseline separation was achieved on an ODS-100V C-18 column (3.0 mu m, 150 mm x 4.6 mm I.D.)with linear gradient elution of acetonitrile-0.1% formic acid. The method was validated for linearity (r(2) > 0.9996), repeatability (R.S.D. < 3.5%), intra- and inter-day precision (R.S.D. < 2.0%) with accuracy (91.8-99.7%), recovery (99.9-105.6%), limits of detection (1.4-22.0 ng), and limits of quantification(3.4-73.4 ng). The 10 compounds were selected for quality assessment of ZGW by using partial least squares-discrimination analysis (PLS-DA). The similarities of 20 batches of ZGW and their classification according to their manufacturers were based on the retention times and peak areas of the characteristic compounds. (c) 2009 Elsevier B.V. All rights reserved.