title: Near-Infrared Spectroscopy Assay of Key Quality-Indicative Ingredients of Tongkang Tablets.
abstract: The objective of this paper is to develop an easy and fast near-infrared spectroscopy (NIRS) assay for the four key quality-indicative active ingredients of Tongkang tablets by comparing the true content of the active ingredients measured by high performance liquid chromatography (HPLC) and the NIRS data. The HPLC values for the active ingredients content of Cimicifuga glycoside, calycosin glucoside, 5-O-methylvisamminol and hesperidin in Tongkang tablets were set as reference values. The NIRS raw spectra of Tongkang tablets were processed using first-order convolution method. The iterative optimization method was chosen to optimize the band for Cimicifuga glycoside and 5-O-methylvisamminol, and correlation coefficient method was used to determine the optimal band of calycosin glucoside and hesperidin. A near-infrared quantitative calibration model was established for each quality-indicative ingredient by partial least-squares method on the basis of the contents detected by HPLC and the obtained NIRS spectra. The correlation coefficient R2values of the four models of Cimicifuga glycoside, calycosin glucoside, 5-O-methylvisamminol and hesperidin were 0.9025, 0.8582, 0.9250, and 0.9325, respectively. It was demonstrated that the accuracy of the validation values was approximately 90% by comparison of the predicted results from NIRS models and the HPLC true values, which suggested that NIRS assay was successfully established and validated. It was expected that the quantitative analysis models of the four indicative ingredients could be used to rapidly perform quality control in industrial production of Tongkang tablets.
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China.
authors.forename: Wenjie
authors.initials: W
authors.lastname: Pan
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China.|Nansha Research Institute, Sun Yat-Sen University, Guangzhou, 511458, China.
authors.forename: Jinfang
authors.initials: J
authors.lastname: Ma
authors.affiliation: Nansha Research Institute, Sun Yat-Sen University, Guangzhou, 511458, China.
authors.forename: Xue
authors.initials: X
authors.lastname: Xiao
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China.
authors.forename: Zhengwei
authors.initials: Z
authors.lastname: Huang
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China.
authors.forename: Huanbin
authors.initials: H
authors.lastname: Zhou
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China. gefahuan@mail.sysu.edu.cn.|Nansha Research Institute, Sun Yat-Sen University, Guangzhou, 511458, China. gefahuan@mail.sysu.edu.cn.
authors.forename: Fahuan
authors.initials: F
authors.lastname: Ge
authors.affiliation: School of Pharmaceutical Sciences, Guangzhou Higher Education Mega Center, Sun Yat-Sen University, No. 132, Waihuan East Road, Guangzhou, 510006, China. pxin_1385@163.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Pan
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002867:Chromones / Q000737:chemistry; D031885:Cimicifuga / Q000737:chemistry; D006027:Glycosides / Q000737:chemistry; D006569:Hesperidin / Q000737:chemistry; D007529:Isoflavones / Q000737:chemistry; D016018:Least-Squares Analysis; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D013607:Tablets / Q000737:chemistry*
chemical_list: C000613355:5-O-methylvisamminol; D002867:Chromones; D006027:Glycosides; D007529:Isoflavones; D013607:Tablets; C121707:7,3'-dihydroxy-4'-methoxyisoflavone; D006569:Hesperidin
keywords: Key quality-indicative ingredients; Near-infrared spectroscopy; Tongkang tablets