Simultaneous determination of ten constituents in chaiqin qingning capsule by high-performance liquid chromatography coupled with triple-quadrupole mass spectrometry
Ting Yu Li1, Xiao Kui Huo2, Lu Zheng3, Chao Wang2, Hai Jian Cong3, Ting Xiang4, Lin Zhang2, Bao Jing Zhang2, Shan Shan Huang2, Bin Wu5, Xin Yu Li6
1 Department of Pharmacy, Dalian Children's Hospital; Academy of Integrative Medicine, College of Pharmacy, Dalian Medical University, Dalian, China
2 Academy of Integrative Medicine, College of Pharmacy, Dalian Medical University, Dalian, China
3 The Department of New Drug, Shanghai Haini Pharmaceutical Co. Ltd., Shanghai 310000, China
4 The Department of New Drug, Yangtze River Pharmaceutical Group, Taizhou 225321, China
5 Shanghai Center for Drug Evaluation and Inspection, SHFDA, Shanghai 201203, China
6 Department of Endocrinology, Dalian Municipal Central Hospital, Affiliated of Dalian Medical University, Dalian, China
Shanghai Center for Drug Evaluation and Inspection, SHFDA, Shanghai 201203
Dalian Medical University, No. 9, South Road of Lvshun, Dalian 116044
Xin Yu Li
Department of Endocrinology, Dalian Municipal Central Hospital Affiliated of Dalian Medical University, Dalian 116033
Source of Support: None, Conflict of Interest: None
Background: Chaiqin Qingning Capsule (CQQNC) was a prescription of Traditional Chinese Medicine with the effects of clearing away heat and removing toxin, harmonizing the exterior and interior, it was widely used in Asian, for example, China and Japan, different batches of the raws materials and different processing time may be the vital factor which raised a challenge to control the quality of the CQQNC. Experimental Methods: In this experiment, a high-performance liquid chromatography-mass spectrometry/MS (HPLC-MS/MS) method was developed to simultaneously determine ten bioactive components for the quality control of CQQNC. Chromatographic separation was achieved using an XBridge BEH C18 column (150 mm × 4.6 mm, 2.5 μm) with a mobile phase composed of 10 mm aqueous ammonium acetate and acetonitrile using a gradient elution in 20 min. This study was conducted by multiple reaction monitoring mode through electrospray ionization resource with a negative ionization mode. Results: The established method was validated with good performance of precision, accuracy, stability, and reproducibility and was utilized to simultaneously quantify ten constituents of CQQNC obtained from seven different batches. Conclusion: It is the first time to report the rapid and simultaneous analysis of the ten compounds in CQQNC by HPLC-MS/MS and apply to determine 10 constituents in 7 batches of CQQNC bought from drug store in china. This method could be considered as good quality criteria to control the quality of CQQNC.
Abbreviations used: CHM: Chinese herbal medicine; TCM: Traditional Chinese Medicine; CQQNC: Triple-quadrupole mass spectrometry Chaiqin Qingning Capsules; HPLC–MS/MS: High liquid chromatography equipped with tandem mass spectrometry; ESI: Electrospray ionization; DP: Declustering potential; CE: Collision energy; RSD: Relative standard deviation; LOD: Limit of detection; LOQ: Limit of quantity.