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OBJECTIVE To analyze the impurity profile of irbesartan and its preparations by LC-MS/MS. METHODS ZORBAX SB-C18 column (4.6 mm×150 mm, 3.5 μm) was used for the separation of the related substances with a mixture of 0.1% formic acid solution (adjusted to pH 3.5 with ammonia) and acetonitrile (62∶38) as the mobile phase by isocratic elution. The structures of the related substances were speculated by ESI-TOF-MS/MS and verified further by reference substances. RESULTS Irbesartan and its related substances were separated under the established chromatographic condition, and a total of 16 related substances were detected. The structures of 10 related substances were verified by reference substances. CONCLUSION The established LC-MS/MS method is effective for separation and identification of the related substances of irbesartan and its preparations, and the results obtained are valuable for its quality control and manufacturing process.
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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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