Abstract:

A method for the simultaneous determination of seven hemostatic drugs in toothpaste was developed using high-performance liquid chromatography-tandem mass spectrometry （HPLC-MS/MS）. The samples were extracted ultrasonically with 5% methanol-0.02 mmol/L disodium ethylenediaminetetraacetate solution. The analytes were separated on an Agilent Poroshell 120 Aq-C₁₈ column （2.1 mm×150 mm, 2.7 μm） column via gradient elution with 0.1% formic acid-methanol as mobile phase. Quantitative analysis was performed by electronic spray ionization under a positive ion and negative ion mode with multiple reaction monitoring （MRM）. The results indicate that the seven hemostatic drugs show good linearity within their respective concentration ranges, with correlation coefficients （R²） greater than 0.998. The limits of detection are 0.05~3.73 μg/g, and the limits of quantitation are 0.17~12.30 μg/g. The average spiked recoveries of the seven hemostatic drugs in two toothpaste matrices are all in the range of 87.5%~111.9%, with RSDs of 0.6%~4.4% （n=6）. The method is simple, sensitive and accurate, making it suitable for the routine determination of these hemostatic drugs in toothpaste.

Key words: toothpaste, hemostatic drugs, tranexamic acid, HPLC-MS/MS, matrix effect