Development and Validation of a UPLC-MS/MS Method for the Quantification of Components in the Ancient Classical Chinese Medicine Formula of Guyinjian

• Published in: Molecules (Basel, Switzerland) Switzerland), 2022-12, Vol.27 (23), p.8611
• Main Authors: Ge, Nan, Li, Zhineng, Yang, Le, Yan, Guangli, Zhang, Aihua, Zhang, Xiwu, Wu, Xiuhong, Sun, Hui, Li, Dan, Wang, Xijun
• Format: Article
• Language: English
• Subjects: Analysis; Chinese medicine; Chromatography, High Pressure Liquid - methods; Chromatography, Liquid; Drugs, Chinese Herbal - analysis; Ethanol; Experiments; Guyinjian; Gynecological diseases; Health aspects; Health services; Herbal medicine; Ions; Kidneys; Mass spectrometry; Medical research; Medicine, Oriental; Methods; multivariate statistical analysis; Oligomenorrhea; Ovaries; Quality control; Quantitative analysis; Reproducibility of Results; Scientific imaging; Selectivity; Stability; Statistical methods; Tandem Mass Spectrometry - methods; UPLC-MS/MS
• ISSN: 1420-3049; 1420-3049
• DOI: 10.3390/molecules27238611

Guyinjian (GYJ) is an ancient classic formula of traditional Chinese medicine used for the treatment of liver and kidney yin deficiency; it was derived from the book "Jing Yue Quan Shu" in the Ming Dynasty. Modern clinical observation experiments have shown that GYJ has a definite therapeutic effect on the treatment of gynecological diseases such as kidney deficiency type oligomenorrhea, climacteric syndrome, intermenstrual bleeding, pubertal metrorrhagia, etc. However, the lack of GYJ quality control studies has greatly limited the development of its wider clinical application. In this study, a validated UPLC-MS/MS method was developed successfully for the first time and used to quantify fourteen compounds in GYJ samples with good specificity, linearity (r = 0.9960-0.9999), precision (RSD% ≤ 3.18%), stability (RSD% ≤ 2.22%) and accuracy (recovery test within 88.64-107.43%, RSD% at 2.82-6.22%). Simultaneously, the determination results of 15 batches of GYJ samples were analyzed by multivariate statistical methods, and it was found that the compounds have a greater influence on batch-to-batch stability, mainly Rehmannioside D, Loganin, Morroniside, Ginsenoside Re, and 3',6-Disinapoylsucrose. The proposed new method has the advantages of high sensitivity, high selectivity, and rapid analysis, which provides a reference for the GYJ quality control study.