Study on Quality Standard for Chuanju Zhitong Capsule

OBJECTIVE To establish the quality standard for Chuanju Zhitong capsule. METHODS TLC was used to qualitatively identify the compound Bupleuri Radix and Chrysanthemum Flos, respectively. HPLC was used to determine the contents of baicalin, baicalein, wogonoside, wogonin and liquiritin. The determination was performed on Kromasil 100-5C₁₈ (250 mm×4.6 mm, 5 μm) column with mobile phase consisted of acetonitrile-0.05% phosphoric acid, gradient elution at flow rate of 1.0 mL·min^-1; the detection wavlength was set at 280 nm; the injection volume was 10 μL. RESULTS TLC spots were clear and well separated without negative interference. The linear range of baicalin, baicalein, wogonoside, wogonin and liquiritin were 10.7-107 μg·mL^-1, 12.12-121.2 μg·mL^-1, 11.2-112 μg·mL^-1, 10.02-100.2 μg·mL^-1 and 10.32-103.2 μg·mL^-1. RSDs of precision, stability and reproducibility tests were <1.8%. The recoveries were 98.34%-101.77%(RSD=1.28%, n=6), 98.69%-101.36%(RSD=1.01%, n=6), 98.46%-101.06%(RSD=0.92%, n=6), 98.67%-101.33%(RSD=1.17%, n=6), 98.43%-100.79% (RSD=0.92%, n=6), respectively. CONCLUSION The established quality standard method is accurate and simple, can be used for the quality control of Chuanju Zhitong capsule, the TLC of Chrysanthemum Flos and Bupleuri Radix can be used for other Chinese herbal compound.