Development of an HPLC Method for the Quality Evaluation of ‘Ge-Gen-Qin-Lian’ Tablets Derived from Traditional Chinese Medicine

摘要

‘Ge-Gen-Qin-Lian’ tablets, made from three important medicinal plants (Radix Puerariae, Radix Scutellaria, and Rhizoma Coptidis), are derived from a traditional Chinese medicine named ‘Ge-Gen-Qin-Lian-Tang’. ‘Ge-Gen-Qin-Lian’ tablets are a widely used botanical drug in China, and can be purchased at the counter. In this study, an HPLC method was developed for the quantification of five important components (puerarin, berberine, baicalin, baicalein and wogonin) in the commercial products of ‘Ge-Gen-Qin-Lian’ tablets, and this method was validated to improve the quality control of this botanical drug. The chromatographic separation was performed on a LicChrospher C18 column (250 mm × 4.6 mm i.d., 5.0 μm particle size) by a gradient elution with methanol and aqueous phases containing 0.05% (v/v) phosphoric acid (pH 3.0 adjusted by triethylamine) at a flow-rate of 0.8 mL min?1. The well-separated chromatogram was achieved within 50 min, and the target components were presented with high resolution. Good linearity (R 2 > 0.9995) was observed over the investigated concentration ranges. The injection repeatability and analysis repeatability for all the investigated components, expressed as relative standard deviation (RSD), were less than 1.0 and 3.5%, respectively. Recoveries of this method for the five components, examined at three concentration levels, were from 94.3 to 104.8% (RSD value <5.0%).