Improvement and Monitoring of Polycyclic Aromatic Hydrocarbons Analytical Method in Herbal Medicine Using GC-MS/MS

Herbal medicines, being primarily natural products, are susceptible to contamination with polycyclic aromatic hydrocarbons (PAHs), including benzo(a)pyrene(BaP), during processes such as heating, drying, or roasting. This study aims to improve the PAHs analytical method registered in the Korean Pharmacopoeia (KP) to facilitate the quality control of herbal medicines. Also, the study involves monitoring specific herbal medicines, selected by an expert advisory committee, to confirm PAH concentrations. The test methods for PAHs have been improved through the modification of the extraction procedures and GC-MS/MS conditions. Additionally, validation was performed to verify the effectiveness of the improved test methods, and as a result of measuring the accuracy with the recovery rate, it was 72.51% to 112.62%. These results fall within the acceptable range specified in the food and drug test method validation guidelines and the AOAC(Association of Official Analytical Chemists) official methods of analysis guideline. As a result of measuring eight types of PAHs of herbal medicines is conducted by the improved test method, BaP was detected in concentrations ranging from ND (Not Detected) to 3.36 μg/kg, PAH4* from ND to 35.92 μg/kg, and PAH8** from ND to 53.01 μg/kg. In Korea, regulatory limit of BaP in herbal medicines less than 5 μg/kg according to the KP. And European Union (EU) set BaP and PAH4 limits at 10 μg/kg and 50 μg/kg in food respectively. 57 herbal medicines did not exceeded these limits. These results confirm the contamination levels of PAHs, such as BaP, in herbal medicines and provide a scientific basis for regulatory safety. In addition, it can be used as a basis for the regulatory limit of BaP in herbal medicines, such as Mume Fruit, Amomum Tsao-ko Fruit , Rehmannia Root, and Prepared Rehmannia Root. These findings can serve as fundamental data for revising BaP quality control standards and management measures. *PAH4(Benz(a)anthracene, Chrysene, Benzo(b)fluoranthene, Benzo(a)pyrene,) **PAH8(Benz(a)anthracene, Chrysene, Benzo(b)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Indeno(1,2,3-cd)pyrene, Dibenz(a,h)anthracene, Benzo(g,h,i)perylene).