Journal of Medicinal Materials, 2023, Vol. 28, No. 3 (pp. 172 -  177)

LC-MS/MS METHOD DEVELOPMENT FOR DETERMINATION

OF ILLEGAL ADDITION OF FIVE H1 ANTIHISTAMINES

IN HERBAL PRODUCTS

Tran Thuy Hanh¹, Mac Thi Thanh Hoa^2, *, Cao Cong Khanh², Vu Ngan Binh³,

Dang Thi Ngoc Lan³, Nguyen Phuong Thao³, Nguyen Quang Hung²,

Tran Cao Son², Nguyen Thi Kieu Anh^3,*

¹National Institute for Drug Quality Control, Hanoi, Vietnam; ²National Institute for Food Control, Hanoi, Vietnam; ³Hanoi University of Pharmacy , Hanoi, Vietnam

*Corresponding author: anhntk@hup.edu.vn and thithanhhoa.mac@gmail.com

(Received May 23^th, 2023)

Summary

LC-MS/MS Method Development for Determination of Illegal Addition of Five H1 Antihistamines in Herbal Products

A sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous analysis of five H1 antihistamine compounds in herbal products. The validation procedure was performed to evaluate selectivity, linearity, LOD, LOQ, accuracy, and precision according to AOAC and ICH guidelines. The linearity of the method estimated using correlation coefficient (R²) was found to be greater than 0.99 for all compounds in the range of concentration 1-50 ng/ml. The LOQs were 1 ng/ml for all target compounds. The accuracy (expressed as recovery) was 80.2-109.1%. The intraday and interday precision were not more than 10.37% and 9.63%, respectively, at the tested concentration levels. The developed method was applied for the determination of five antihistamines in herbal products collected from markets, websites or received from users. As a result, 6 in 35 samples (17.1%) were adulterated with the target compound at concentration ranging from 0.048 to 3.13 mg/g. The proposed method is suitable for monitoring the adulteration of H1 antihistamine compounds in herbal products.

Keywords: LC-MS/MS, Method, H1 antihistamine, Adulteration, Herbal product.

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