Characteristic fingerprint and multi-components quantitative determination for Fuke Qianjin Capsules by HPLC

• Published in: Zhongguo zhongyao zazhi Vol. 44; no. 8; p. 1564
• Main Authors: Wang, Kang-Hua, Zhang, Ying-Tao, Yang, Xiu-Wei, Xu, Wei, Zhang, Peng, Peng, Kai-Feng, Li, Fu-Jun, Gong, Yun, Liu, Ni-Fu
• Format: Journal Article
• Language: Chinese
• Published: China 01.04.2019
• Subjects: 14-deoxy-11,12-didehydroandrographolide; quality control; Fuke Qianjin Capsules; jatrorrhizine; multi-index quantitative analysis; genistin; HPLC characteristic fingerprint; andrographolide
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.20181220.007

To establish an HPLC characteristic fingerprint method of Fuke Qianjin Capsules,and determine the contents of its main components. The analysis was carried out on a Kromasil 100-5-C18 analytical column(4. 6 mm ×250 mm,5 μm) with gradient elution by acetonitrile(A)-0. 1% phosphoric acid aqueous solution(B),a flow rate at 1. 0 m L·min-1 and the detection wavelength of 254 nm.The column temperature was 30 ℃,and the injection volume was 10 μL. The determination method of genistin,jatrorrhizine,andrographolide and 14-deoxy-11,12-didehydroandrographolide index components were studied methodologically. The common mode of the characteristic fingerprint of Fuke Qianjin Capsules was set up with 8 common peaks,which were identified as genistin,jatrorrhizine,palmatine,berberine,andrographolide,14-deoxy-11,12-didehydroandrographolide,Z-ligustilide,and Z-3-butylidenephthalide,respectively,in comparison with the references. The similarities of 20 batches of Fuke Qianjin Capsules samples were above 0. 95. All of the above-mentioned 4 analytes could be well separated under the optimized chromatographic conditions. RSD of precision and repeatability experiment were both less than 1. 5%,and the sample solution was stable during 72 h. All of the compounds had a good linearity and linear range. The contents of genistin,jatrorrhizine,andrographolide,and 14-deoxy-11,12-didehydroandrographolide in 20 batches of Fuke Qianjin Capsules samples were 28. 66-56. 04,94. 77-197. 92,1 705. 33-4 148. 93 and 462. 16-1 225. 96 μg in each capsule,respectively. The developed HPLC characteristic fingerprint and quantitative analysis methods were reliable,accurate and sensitive,and could be used effectively evaluate the quality of Fuke Qianjin Capsules samples.