Objective To establish a solid-phase extraction-high-performance liquid chromatography (SPE-HPLC) method for the determination of paracetamol, caffeine, chlorphenamine maleate, daurisoline, dauricine and buddleoside in compound asiatic moonseed, paracetamol and chlorphenamine maleate tablets.

Methods The samples were pretreated using an MCX solid-phase extraction column. A Waters XBridge C₁₈ column (250 mm×4.6 mm, 5 μm) was employed, with a mobile phase consisting of phosphate buffer solution (11.5 g of ammonium dihydrogen phosphate, adding 1 mL of phosphoric acid, and diluting to 1 000 mL with water) - acetonitrile for gradient elution. The flow rate was set at 1.0 mL/min, and the detection wavelengths were 272 nm (0-20 min, for paracetamol and caffeine), 225 nm(20-48 min, for daurisoline, chlorphenamine maleate, and dauricine), and 334 nm (48-55 min, for buddleoside). The column temperature was maintained at 30°C.

Results Paracetamol, caffeine, daurisoline, chlorphenamine maleate, dauricine and buddleoside exhibited good linearity within the concentration ranges of 120.09-2,401.80, 6.04-120.76, 4.01-80.23, 29.94-598.80, 5.93-118.58 μg/mL, and 2.46-49.29 μg/mL, respectively. The linear correlation coefficients were all greater than 0.9997. The average recoveries were 99.39%, 98.24%, 88.13%, 95.32%, 92.54%, and 96.89%(RSD ≤ 2.65%, n=9), respectively.

Conclusion The method established in this study can simultaneously determine multiple components in compound asiatic moonseed, paracetamol and chlorphenamine maleate tablets and meets the requirements of methodological validation. It can provide technical support for the quality control and standard revision of this preparation.

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