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To establish a method for the determination of 22 mycotoxins in pharmaceutical excipients by ultra-high performance liquid chromatography-ion mobility time-of-flight mass spectrometry (UHPLC-IM TOF MS).
The samples were separated on a Waters CORTECS® UPLC® C18(100 mm×2.1 mm，1.6 μm) column by gradient elution at a flow rate of 0.25 mL·min-1 using 0.1% formic acid and a mixture of acetonitrile and methanol (60:40) as the mobile phase. The column temperature was maintained at 35 ℃. MSe data acquisition mode was chosen and electrospray ion source operating in the positive/negative ionization mode for data acquisition was applied. The external standard method was used for quantification.
22 mycotoxins showed good linear relationships within their respective ranges (r>0.998 5). The limits of detection were 0.1-2.0 μg·kg-1. The recoveries of 22 mycotoxins at three levels were in the range of 80.4%-118.2%，and the RSDs were 0.20%-8.8%. The matrix effect of 22 mycotoxins was not obvious. The method was applied to the detection of 32 batches of corn starch and 167 batches of dextrin. Aflatoxin B1，fumonisins B1 and B2，and zearalenone were detected in some batches.
The method is accurate，efficient and stable. It can be used in quality control of mycotoxins in pharmaceutical excipients，and provides technical supports for the risk assessment of mycotoxins.
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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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