Abstract
BackgroundConcentrated Gegen Tang (GT) granule is a widely available traditional Chinese medicinal product for the treatment of cold and flu. There was no reliable analytical method available for the quality assessment of GT granules.MethodsAn HPLC method with an Agilent Zorbax SB-Phenyl Stablebond column (250 × 4.6 mm, 5 μm) was developed and validated. The mobile phase gradient was a mixture of 0.1% trifluoroacetic acid (TFA) in acetonitrile (ACN) and 0.1% TFA in water. The detection with a diode-array detector was set at 207, 230, 250 and 275 nm. Seven components, namely puerarin, daidzein, paeoniflorin, cinnamic acid, glycyrrhizin, ephedrine and pseudoephedrine were selected as marker compounds for the evaluation.ResultsThe regression equations revealed good linear relationships (correlation coefficients: 0.9994–0.9998) between the peak areas and concentrations. The recovery was between 98.8% and 101.7% with good precision and accuracy. The quality of GT granule from four different manufacturers was evaluated with this newly developed method. Samples from four manufacturers showed similar profiles but contents of the detected markers varied significantly among manufacturers and batches.ConclusionA new method using high performance liquid chromatography (HPLC) has been developed for simple and reliable quality control of commercial concentrated GT granules. Sensitivity was increased by multi-wavelength detection. The contents of selected marker components in GT granules varied significantly among manufacturers and batches, making it necessary to evaluate the quality of concentrated GT granules in the market.
Highlights
Concentrated Gegen Tang (GT) granule is a widely available traditional Chinese medicinal product for the treatment of cold and flu
We report an high performance liquid chromatography (HPLC) method first developed and validated for the quality control of GT granule
A multi-component HPLC method with a simple extraction procedure has been developed for the simultaneous quantitation of seven markers in commercially available concentrated GT granules
Summary
Concentrated Gegen Tang (GT) granule is a widely available traditional Chinese medicinal product for the treatment of cold and flu. Listed in Shanghan Lun (Discussion of Cold-induced Disorders) by Zhang Zhongjing of the Han Dynasty, Gegen Tang (GT), a decoction of Radix Pueraria Lobatae (Gegen), is a classical formula of traditional Chinese medicine. It is widely used in China and South East Asia for treating cold (page number not for citation purposes). Modern pharmacological studies have revealed that it can alleviate upper respiratory tract diseases, trigeminal neuralgia, lumbar muscle strains, tension headaches, arthralgia, ischemic stroke, rheumatoid arthritis, dysentery and nettle rash. The formula of GT has been developed into a concentrated granule form which has advantage over the traditional decoction
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