Improvement of Quality Standard for Longze Xiongdan Capsules
Objective To improve the quality standard of Longze Xiongdan Capsules.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify the cimifugin and 5-O-methylvisamminol in Saposhnikoviae Radix,and the durability was investigated.High-performance liquid chromatography(HPLC)method was used to simultaneously determine the contents of the above two components in the preparation;the chromatographic column was Wondasil C18 column(200 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 0.8 mL/min,the detection wavelength was 254 nm,the column temperature was 30℃,and the injection volume was 20 μL.Results The TLC chromatograms had clear spots and good resolution,and the negative reference had no interference.The linear ranges of cimifugin and 5-O-methylvisamminol were 0.051-1.020 μg,0.025-0.499 μg(R2 = 1.000)respectively.The limits of detection of the above two components were both 0.1 μg/mg,and their limits of quantification were both 0.3 μg/mL.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above two components were 96.20%,91.40%,with the RSDs of 1.09%,1.89%(n = 6)respectively.Conclusion The established method is specific,repeatable,durable and stable,which can provide a reference for the quality control of Longze Xiongdan Capsules.
Longze Xiongdan CapsulesSaposhnikoviae Radixcimifugin5-O-methylvisamminolTLCHPLCquality control
万方数据
维普
