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An HPLC-MS/MS method was developed for simultaneous determination of dexrabeprazole and levrabeprazole concentrations in human plasma by using a chiral chromatographic column. It was used in the pharmacokinetic study of dexrabeprazole sodium for injection.
AB Sciex API4000 liquid-mass spectrometer with ESI ion source was selected and the Daicel CHIRALPAK® IC (250 mm×4.6 mm, 5 μm) chiral chromatographic column were used with the mobile phase of acetonitrile-10 mm ammonium acetate (75∶25, v/v) at a flow rate of 1 mL·min-1. The isotopic [2H3]-dexrabeprazole was used as internal standard. The plasma samples were analyzed using 2 μL supernatant after the protein was precipitated by acetonitrile. Forty healthy volunteers participated in the pharmacokinetic study of dextrorabeprazole sodium for injection.
The established HPLC-MS/MS method has good linear relationship for dexrabeprazole in the range of 1.00~1 500 μg·L-1, and for levrabeprazole in the range of 1.50~1 500 μg·L-1. The results show that the linearity, selectivity, lower limit of quantification, precision and accuracy, recovery, matrix effect as well as stability all meet the test requirements.
The HPLC-MS/MS method established in this laboratory has strong selectivity, high sensitivity and good chiral separation. It is suitable for the concentration determination of dexrabeprazole and levrabeprazole in human plasma, and has been successfully applied to the pharmacokinetic study of dexrabeprazole sodium for injection.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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