Multiwavelength Detection and Multivariate Analysis for Tongzhi Surunjiang Preparation with Substitute Reference Substance Method by High Performance Liquid Chromatography
YU Xin-lan1,bAO Rong1, CAI Lei1, SUN Lei1,2,3*
1.Xinjiang Institute for Food and Drug Control, Urumqi 830004, China; 2.National Institutes for Food and Drug Control, Beijing 100050, China; 3.School of Pharmacy, Xi��an Jiaotong University, Xi��an 710061, China
Abstract��OBJECTIVE To propose a holistic strategy for quality control of Chinese patent medicines, and establish an HPLC analytical method for Tongzhi Surunjiang preparation according to the strategy. METHODS The strategy contained three steps.The first step was multi-wavelength chromatographic detection.The second step was multivariate analysis for identification and assay. The third step was to establish substitute reference substance method.The preparations were extracted by ultrasound with methanol, chromatography was performed on ODS column with gradient elution with acetonitrile and 0.1%phosphoric acid aqueous solution.The detection wavelengths were set at 270, 350, 410 and 440 nm.The radar chart, HCA heatmap, principal component analysis and cosine similarity were used for data analysis.At last, linear calibration using two reference substances, relative retention time method and PDA spectrum method were used for peak identification, and relative correction factor method was used for quantitative analysis. RESULTS The multi-components determination method and fingerprint analysis met the method validation requirements. Data analysis showed that there were some differences among the samples of different manufacturers. Strong characteristic peaks for classification were gallic acid, chebulinic acid, chebulea fructus, sennae folium, sennae folium and crocin��.CONCLUSION The method is specific, with low cost, and could be used to accurately control the quality of Tongzhi Surunjiang preparation.
CAO X R, XIANG Y, FENG J Q, et al.Determination of sennoside A and B in Tongzhi Surunjiang Capsules by HPLC. Chin Pharm(�й�ҩʦ), 2014, 17(8):1311-1313.
[2]
YUSUFUJIANG A, MANERDAN N. Determination of colchicine in Tongzhi Surunjiang Capsules by HPLC. J Med Pharm Chin Min(�й�����ҽҩ��־), 2008, 14(9):31-33.
[3]
ZHONG J, XU F, YAN M, et al. Determination of the content of colchicine in Tongzhi Surunjiang Capsules by RP-HPLC. J Chin Pharm(�й�ҩ��), 2009(3):200-201.
[4]
ZHAO S H, QI M L, LIU D W. Determination of gallic acid of Tongzhi Surunjiang Capsules by RP-HPLC . Pharm J Chin PLA(��ž�ҩѧѧ��), 2007, 23(5):392-394.
[5]
CHEN H J. Determination of gallic acid in Tongzhi Surunjiang Capsules by HPLC. Qinghai Med J(�ຣҽҩ��־), 2007, 37(6):69-71.
[6]
JI Z C, SUN G X. Mornitoring the quality of compound Danshen Dropping pills by four-wavelength HPLC fingerprints coupled with simultaneous determination of 8 components. J Shenyang Pharm Univ(����ҩ�ƴ�ѧѧ��), 2017(6):495-502.
[7]
ZHOU J S, ZHANG H K, HUANG Y Y, et al.Simultaneous determination of ten chemical components in Yupingfeng San by HPLC under multiple UV wavelengths. Chin J Pharm Anal(ҩ�������־), 2016(6):1072-1081.
[8]
CHEN P, JIN H Y, SUN L,et al.Application of extractive reference substance in holistic quality control of traditional Chinses medicine. Chin J Pharm Anal(ҩ�������־), 2016(2):185-195.
[9]
WANG M, JIANG Y, CHEN X Q,et al.Simultaneous determination of five compounds in extract of Penthorum chinsense Pursh. using quantitative analysis of multi-components by single-marker. Chin Pharm J(�й�ҩѧ��־),2016, 51(18):1545-1550.
[10]
ZHANG X L, ZHOU Q F, LEI H L, et al. Simultaneous determination of six oligosaccharide esters in Polygalae Radix by quanitative analysis of multicomponents by singlemarker. Chin Pharm J(�й�ҩѧ��־),2015,50(9):808-813.
[11]
SUN L, JIN H Y, PANG Y, et al. Two reference substances for determination of multiple components(��): linear calibration using two reference substances for identification of chromatographic peaks. Chin J Pharm Anal(ҩ�������־), 2013,33(8): 1424-1430.
[12]
SUN L, PANG Y, JIN H Y, et al. Two reference substances for determination of multiple components(��): influence of detection wavelength selection for quantitative analysis. Chin J Pharm Anal(ҩ�������־),2013,33(9):1578-1586.
[13]
SUN L, JIN H Y, TIAN R T, et al. A simple method for HPLC retention time prediction: linear calibration using two reference substances. Chin Med, 2017, 12(1):16-27.
[14]
CHEN R, ZHANG C, ZHANG H F, et al.Determination of Multiple Components in Shuanghuanglian Preparations by Liner Calibration with Two Reference Substances Assisted with Chromatographic Peaks Identification. Chin J Exp Tradit Med Form(�й�ʵ�鷽��ѧ��־), 2018(8):40-48.
[15]
LIU L N, SUN L, TIAN R T, et al.Fingerprint analysis of swertiachirayita by linear calibration using two reference substances with PDA assistance. Chin Pharm J(�й�ҩѧ��־), 2015, 50(4):287-292.
[16]
HE B, YANG S Y, ZHANG Y, et al. A new method of calibration and positioning in quantitative analysis of multi components by single marker. Acta Pharm Sin(ҩѧѧ��), 2012,14(12):1653-1659.
[17]
SUN L, JIN H Y, MA S C, et al.Guideline of substitute reference substance method for evaluation of traditional Chinese medicine. Chin Pharm J(�й�ҩѧ��־), 2015, 50(4):284-286.
[18]
SUN G X, HOU Z F, ZHANG C L, et al. Comparison between the qualitative similarity and the quantitative similarity of chromatographic fingerprints of traditional Chinese medicines. Acta Pharm Sin(ҩѧѧ��),2007,42(1):75-80.
[19]
SUN G X, SONG Y, BI Y M, et al. Quality control system of overall qualitative similarities and overall quantitative similarities of chromatographic fingerprints. Cent South Pharm(����ҩѧ), 2007, 5(3):263-267.
[20]
SUN G X, REN P P, BI Y M, et al. Quality assessment on high performance liquid chromatographic fingerprints of Ginkgo leaf extract and dipyridamole injection by double qualitative similarities and double quantitative similarities. Chin J Chrom(ɫ��), 2007, 25(4):518-523.
2018, Vol. 53 
