Determination of domperidone in Domperidone Tablets produced by different manufacturers by ultra performance liquid chromatography-tandem mass spectrometry
GENG Jing LYU Lingyan FENG Xingyue JIANG Zhitao LIU Chundi
Graduate Workstation, Zhangjiagang Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province, Zhangjiagang 215600, China
Abstract：Objective To establish a method for the determination of domperidone in Domperidone Tablets by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and to compare the contents of domperidone in Domperidone Tablets produced by different manufacturers. Methods BEH C18 column (2.1 mm × 50 mm, 1.7 μm) was used. The mobile phase was methanol∶2 mmol/L ammonium acetate aqueous solution (85∶15, V/V). The injection volume was 2 mL, the column temperature was 30℃, and the flow rate was 0.2 mL/min. Multiple Reaction Monitoring Model (MRM) was used for positive ion pattern detection. Results Domperidone was well separated within 3 min and showed a good linear relationship with peak area in the concentration range of 10.6-5300 ng/mL. The linear regression equation was Y = 85.362 X+30 067. The limit of detection was 1.06 ng/mL, and the limit of quantitation was 10.6 ng/mL. The average recoveries was 99.2% with the relative standard deviation (RSD) being 1.7%. The contents of domperidone in Domperidone Tablets produced by different manufacturers were 10.016, 10.147, 10.092, 10.123, 10.109 and 10.075 mg respectively, which met the requirements of the 2015 edition of the Pharmacopoeia of the People′s Republic of China (Part Ⅱ). Conclusion The method is simple, rapid, reproducible and sensitive. It is suitable for rapid quantitative analysis of domperidone.
2019, Vol. 16 
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