1 Abstract
For the 2025 Edition of the Chinese Pharmacopoeia, the assay item of Juhong Tanke Oral Solution is revised from single-component determination of naringin to simultaneous quantification of naringin and rhoifolin, and the chromatographic elution mode is upgraded from isocratic elution to gradient elution. In accordance with the chromatographic specifications specified in the 2025 Edition of Chinese Pharmacopoeia, an HPLC testing method using C18 chromatographic column was established for the content determination of naringin and rhoifolin in Juhong Tanke Oral Solution.
Method validation results show that for reference standard solution repeatability test: the RSD of retention time for naringin and rhoifolin is ≤0.046%, the RSD of peak area ≤0.426%; their tailing factors are 1.027 and 1.043 respectively. The theoretical plate number of naringin peak reaches 309240, complying with the requirements of the 2025 Edition of Chinese Pharmacopoeia. This established method can serve as technical reference for routine assay of the two marker constituents in the preparation.
2 Instrument Conditions
Persee L820 High Performance Liquid Chromatograph, consisting of:
Model L820-P22 binary high-pressure solvent delivery pump
Model L820-A11 auto-sampler
Model L820-C11 column oven
Model L820-D10 UV-Vis detector
LCWin V5.0 Standard Edition chromatography workstation
Model L820-C304100001 solvent tray
