INTRODUCTION: Traditional Chinese medicine plays a very important role in the healthcare system of China and thus the quality control of medicinal herb products is of paramount concern. OBJECTIVE: To establish a simple and effective high-performance liquid chromatography (HPLC) method to evaluate the quality of Daochi pill. METHODOLOGY: Two HPLC methods were developed for the determination of 16 marker components in Daochi pills. In method A, the analytes were separated on a Lichrosorb C(18) column using a gradient elution of methanol and 1% aqueous phosphoric acid (pH 2.9, adjusted by triethylamine). In method B, the separation was achieved on an Agilent Eclipse Plus C(18) column using a gradient elution of methanol and 3% aqueous phosphoric acid (pH 2.0, adjusted by triethylamine) in a gradient elution mode. RESULTS: Methods were linear over the range 0.27-500 microg/mL (r(2) >or= 0.9995). Accuracy, precision and repeatability were all within the required limits. The mean recoveries measured at three concentrations were higher than 95% with RSD <or= 4% for the targets. CONCLUSION: The established methods are simple and can be used as tools for quality evaluation and control of this natural product.
INTRODUCTION: Traditional Chinese medicine plays a very important role in the healthcare system of China and thus the quality control of medicinal herb products is of paramount concern. OBJECTIVE: To establish a simple and effective high-performance liquid chromatography (HPLC) method to evaluate the quality of Daochi pill. METHODOLOGY: Two HPLC methods were developed for the determination of 16 marker components in Daochi pills. In method A, the analytes were separated on a Lichrosorb C(18) column using a gradient elution of methanol and 1% aqueous phosphoric acid (pH 2.9, adjusted by triethylamine). In method B, the separation was achieved on an Agilent Eclipse Plus C(18) column using a gradient elution of methanol and 3% aqueous phosphoric acid (pH 2.0, adjusted by triethylamine) in a gradient elution mode. RESULTS: Methods were linear over the range 0.27-500 microg/mL (r(2) >or= 0.9995). Accuracy, precision and repeatability were all within the required limits. The mean recoveries measured at three concentrations were higher than 95% with RSD <or= 4% for the targets. CONCLUSION: The established methods are simple and can be used as tools for quality evaluation and control of this natural product.