Abstract

Wang G. L. , Wei M. , Wang J. , Lu Y. , Mahady G. B. and Liu D. *

The development and optimization of quality control and assurance methods for plant based medicines to assure batch-to-batch consistency and standardization is an essential part of the production process. This is even more important for Traditional Chinese Medicine (TCM) formulas that may contain several different medicinal plant drugs. The goal of the present work was to optimize high-performance liquid chromatography-photodiode array detection (HPLC-PDA) fingerprinting method for a TCM herbal formula (menoprogen) used for the management of menopause. Ten batches of the combination herbal product were obtained and extracted in methanol-water. The extracted samples were analyzed by HPLCPDA and separated on a Kromasil ODS C18 column (4.6 × 250 mm, 5 μm) with a mobile phase of 0.1% phosphoric acid (0.1%) -acetonitrile in a gradient elution over 135 min using a PDA (205 nm) for analysis and compared with reference standards. The developed HPLC-PDA method clearly identified the main 21 common peaks from a methanol extract of 10 batches of menoprogen with excellent precision and reproducibility. The results demonstrate that the HPLC-PDA chemical fingerprinting methods described in this work are feasible for the comprehensive quality evaluation of the medicinal plant formulation, and thus can be used for the chemical standardization and batch-to-batch consistency of this product.