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OBJECTIVE To develop and validate an HPLC analytical method for finerenone, based on the concept of analytical quality by design (AQbD). METHODS LC-MS was used to identify the impurity fractions of finerenone API, and then the HPLC chromatographic conditions of finerenone were screened and optimized by analytical factorial design (25-1), which examined several factors, such as the acetonitrile proportion at the beginning of the elution gradient, the acetonitrile proportion at the end of the elution gradient, the elution time, the column temperature and the concentration of phosphoric acid aqueous solution, to evaluate the relationship between the critical method attributes (CMAs) and the critical method parameters (CMPs), and to generate the method operable design region (MODR), and finally perform methodological validation. RESULTS The effects of each CMPs on CMAs were analyzed, and the optimized chromatographic conditions from MODR were column temperature 45 ℃, 0.06% phosphoric acid water, gradient elution starting with 5% acetonitrile and ending with 45% acetonitrile, running for 16 min. The established finerenone analysis method had good precision, stability, linearity and sample recovery results. CONCLUSION The chromatographic conditions established based on the AQbD concept can achieve a good separation of finerenone from impurities, accurately evaluate the content of finerenone, and effectively control the quality of the drug.
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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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