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To develop a rapid, specific and sensitive UPLC-MS/MS method for the determination of vonoprazan in human plasma and its application in a bioequivalence study of two types of tablets.
A single dose, two-cycle, two products, and self-cross controlled trial design on bioequivalence was used. Plasma samples were collected from healthy human volunteers at different time points after oral administration with the test or reference product of 20 mg fumarate vonoprazan tablets under both fasting and fed conditions, respectively. The plasma samples were treated by acetonitrile protein precipitation and then analyzed by UPLC-MS/MS. Chromatographic separation of vonoprazan was achieved using a Waters ACQUITY UPLC® BEH C18（50 mm × 2.1 mm, 1.7 μm）column at 40 ℃. The mobile phase consisted of water (containing 0.1% formic acid) for eluent A and acetonitrile (containing 0.1% formic acid) for eluent B under a gradient elution. An electrospray ionization (ESI) with multiple reaction monitoring (MRM) mode was used to monitor the precursor-product ion transitions of m/z 346.1→315.4 for vonoprazan and m/z 350.1→316.2 for vonoprazan-d4.
The rang of linearity was 0.30-50.00 ng·mL-1（r>0.998 9）, and the LLOQ was 0.30 ng·mL-1. Intra- and inter-day precision values were within 5.7%, and intra- and inter-day accuracy values were ranged from -2.15% to 0.82%. Recovery, specificity, matrix effect and stability met the guiding principles. This method has been successfully applied to study the bioequivalence of vonoprazan fumarate tablets. The Cmax of the test product in postprandial and fasting tests were (29.08±11.59) ng·mL-1 and (26.87±8.14) ng·mL-1, respectively, and the AUC0-t was (258.90±87.71) h·ng·mL-1 and (223.08±43.27) h·ng·mL-1, respectively. The Cmax of the reference product in postprandial and fasting tests were (28.73±10.25) ng·mL-1 and (26.93±8.09) ng·mL-1, respectively, and the AUC0-t was (250.33±73.13) h·ng·mL-1 and (227.56±46.26) h·ng·mL-1, respectively. In the postprandial trial, the 90% CIs for the geometric mean ratios of Cmax, AUC0-t and AUC0-∞ of the test and reference products were 88.64%-112.28%, 96.1%-108.2% and 96.6%-108.7%, respectively. And in the fasting trail, the 90% CIs for the geometric mean ratios of Cmax, AUC0-t and AUC0-∞ of the test and reference products were 94.01%-106.23%, 94.71%-102.03% and 95.18%-102.47%, respectively.
This validated method has the advantages of simplicity, rapid, and high sensitivity. Test vonoprazan fumarate tablets are bioequivalent to the reference product.
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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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