Four exogenously-polluted components in Tianwang Buxin pills analyzed via TLC and UPLC-QQQ-MS

doi:10.19803/j.1672-8629.20230572

Abstract

Abstract: Objective To tentatively study abnormal components of Tianwang Buxin pills on sale that were found in quality analysis and establish an analytical method for simultaneous determination of four exogenously-polluted components using TLC and UPLC-QQQ-MS. Methods One hundred and fifty-eight batches of samples of Tianwang Buxin pills were qualitatively identified by using the TLC method and optimizing the unfolding system. For abnormal spots, HPLC-Q/TOF-MS was used for identification and confirmation of components. UPLC-QQQ-MS was adopted for quantitative analysis. Results Among the 158 batches of samples, four types of exogenously-polluted components, including Berberine hydrochloride, Epiberberine, Coptisine hydrochloride and Palmatine chloride, were detected in nine batches. These four types of components were linear within the range of 0.97~483.34, 0.98~98.49, 1.00~100.50 and 0.88~87.75 ng·mL^-1, respectively. The recovery ranged from 99.30% to 103.99%, and the RSD from 0.90% to 2.62% (n=6). The contents of these components were 20.3~104.1, 1.0~17.6, 0.4~30.6 and 3.2~24.8 μg·g^-1, respectively. Conclusion This method is simple, accurate, and highly specific, which can provide reference for quality control of Tianwang Buxin pills.

Key words: Tianwang Buxin pills, thin layer chromatography, ultra high performance liquid chromatography, triple quadrupole mass spectrometry, exogenously, polluted

CLC Number:

R927.11

ZHANG Zan, ZHANG Hui, HE Songhua, LUO Yi. Four exogenously-polluted components in Tianwang Buxin pills analyzed via TLC and UPLC-QQQ-MS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 156-162.

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https://www.zgywjj.com/EN/Y2024/V21/I2/156

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