Multicomponent Analysis of Liuwei Dihuang Pills by a Single Marker Quantification Method and Chemometric Discrimination of Fingerprints

Lin Yang; Yan Li; Yuanfang Hou; Yongfu Wu; Lihong Tan; Zhenqiang Mu; Zhaojing Zhu; Dan He

doi:10.1155/2023/6648668

Multicomponent Analysis of Liuwei Dihuang Pills by a Single Marker Quantification Method and Chemometric Discrimination of Fingerprints

J Anal Methods Chem. 2023 Sep 15:2023:6648668. doi: 10.1155/2023/6648668. eCollection 2023.

Authors

Lin Yang¹, Yan Li¹, Yuanfang Hou¹, Yongfu Wu², Lihong Tan¹, Zhenqiang Mu¹, Zhaojing Zhu¹, Dan He³

Affiliations

¹ Chongqing Pharmaceutical Preparation Engineering Technology Research Center, Chongqing Medical and Pharmaceutical College, Chongqing 401331, China.
² Traditional Chinese Medicine Factory Co. Ltd., Taiji Group Chongqing, Chongqing 402284, China.
³ Chongqing Research Center for Pharmaceutical Engineering, College of Pharmacy, Chongqing Medical University, Chongqing 400016, China.

Abstract

An effective and comprehensive quality evaluation method for Liuwei Dihuang pills (LDP) was established by the simultaneous determination of 8 active components in LDP by the quantitative analysis of multicomponents by single marker (QAMS) method and high-performance liquid chromatography (HPLC) fingerprint combined with chemometrics. These 8 active components were determined by QAMS and the external standard method (ESM), and the quantitative results of the two methods were compared to validate the accuracy and feasibility of the QAMS method. 8 active components showed good linear relationships within their ranges, whose average recoveries were 99.7∼102.3%. No significant difference was found (P > 0.05) in the quantitative results determined by QAMS and ESM. Furthermore, the fingerprint of LDP was also established, with 11 common peaks identified, and the similarity of the fingerprints of 21 batches of LDP was greater than 0.95. The 21 batches of LDP were basically divided into 3 groups by hierarchical cluster analysis (HCA) and principal component analysis (PCA), and 3 differential markers were screened out by orthogonal partial least squares discriminant analysis (OPLS-DA). The established QAMS method is accurate, economical, fast, and convenient and can simultaneously determine the content of 8 active components in LDP. HPLC fingerprint combined with chemometric analysis more comprehensively evaluated the quality consistency of different batches of LDP and analyzed the markers that cause quality differences between batches. It can provide a scientific basis and reference of quality consistency evaluation for the manufacturers and drug regulatory departments of the preparation.