To establish a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of propofol medium/long chain fat milk in Beagle dogs plasma, and to investigate the pharmacokinetics and bioequivalence of the reference preparation of propofol medium/long chain fat milk injection and the subject preparation after intravenous injection in Beagle dogs.
The protein precipitation method was used for pretreatment, and the chromatographic column was Inert Sustain AQ-C18 column (50.0 mm×2.1 mm, 5 μm). Mobile phase: 0.1% ammonia-ammonium acetate aqueous solution, flow rate: 0.4 mL·min-1, column temperature: 40 ℃; the injection volume was 10 μL; ion source: electrospray ion source, negative ion mode, multi-reaction detection. The specificity, standard curve and lower limit of quantitation, precision and recovery, stability and reproducibility of the method were investigated.
The linear range of propofol was 0.05-10.00 μg·mL-1, the lower limit of quantitation was 0.05 μg·mL-1, the accuracy was 94.2%-105.0%, the intra-day and inter-day precision was less than 20%, and the stability was good. The Cmax of the reference preparation and the test preparation were (8.75±2.66) and (8.15±2.78)μg·mL-1 and the AUClast were (1.71±0.45) and (1.88±0.42) h·μg·mL-1, respectively.
A simple, sensitive and accurate LC-MS/MS method is established for the determination of propofol.
| 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 |