Objective  To determine and analyze the content of 45 inorganic elements in Fufang Xiling Jiedu preparation and to provide a reference for the safety detection of Fufang Xiling Jiedu preparation.

Methods  Inductively coupled plasma mass spectrometry (ICP-MS) was used to ascertain the concentrations of 45 inorganic elements, including Li, B, Al, K, Zn and As from 16 batches of Fufang Xiling Jiedu preparation which were gathered. The content determination findings were plotted as heatmaps, Pearson correlation analysis plot, PCA scatter plots, fingerprints, and control maps. The Pearson correlation analysis and PCA analysis were performed on the content determination results of 16 batches using SPSS 21.0, to evaluate the safety and quality uniformity of Fufang Xiling Jiedu preparation.

Results  The inorganic elements in Fufang Xiling Jiedu preparation were dominated by K and Ca. The content of different elements in the sample could be categorised into 5 levels. The content of various elements in different batches of Fufang Xiling Jiedu preparation was similar. Pb, Cd, As, Hg and Cu were all within the safety limit as those specified in the Chinese Pharmacopoeia. Co, Y, Sm, Gd, Dy, Th, Al, Si, Fe, Sb and Tl were the characteristic inorganic elements of Fufang Xiling Jiedu preparation.

Conclusion  This method is easy to operate and suitable for the determination of inorganic elements in Fufang Xiling Jiedu preparation, providing references for the clinical medication safety.

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