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The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS
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Jian LIU1, Shanping MA2, *, Zhixia XIE2, Xiaolu CHEN3, Hui ZHANG3
Pharmacy Today | 2026, 36(3) : 175 - 178
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Pharmacy Today | 2026, 36(3): 175-178
The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS
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Jian LIU1, Shanping MA2, *, Zhixia XIE2, Xiaolu CHEN3, Hui ZHANG3
Affiliations
  • 1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China
  • 2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China
  • 3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China
Published: 2026-03-25 doi: 10.12048/j.issn.1674-229X.2026.03.003
Outline
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OBJECTIVE

To establish a UPLC-MS/MS method for the determination of genotoxic impurities dimethyl sulfate (DMS）and diethyl sulfate (DES) in Finerenone bulk drug.

METHODS

The analytes were separated on an Agilent Poroshell 120 HILIC-Z (100 mm × 2.1 mm, 2.7 μm) column. The mobile phase consisted of a formic acid, water, and acetonitrile solution in a volume ratio of 0.5:300:700 (v/v/v). The flow was set at 0.3 mL·min-1, with a column temperature of 30 ℃ . The target compounds were analyzed in the negative ion MRM mode.

RESULTS

DMS and DES showed good linear relationships within the ranges of 0.75-15.00 ng·mL-1, with correlation coefficients (r) being 0.999 9. The detection limits of the method were 0.23 μg·g-1 and the quantification limits were 0.75 μg·g-1. The recoveries were both 107.53%-109.79%. No DMS and DES were detected in 3 batches of Finerenone.

CONCLUSION

This method is accurate, specific, and sensitive. It could be used for the simultaneous determination of DMS and DES in Finerenone bulk drug, thereby providing technical support for the quality control of Finerenone.

UPLC-MS/MS  /  genotoxic impurities  /  dimethyl sulfate  /  diethyl sulfate  /  finerenone
刘健, 马珊萍, 谢志霞, 陈小露, 张辉. UPLC-MS/MS法测定非奈利酮原料药中遗传毒性杂质硫酸二甲酯和硫酸二乙酯. 今日药学, 2026 , 36 (3) : 175 -178 . DOI: 10.12048/j.issn.1674-229X.2026.03.003
Jian LIU, Shanping MA, Zhixia XIE, Xiaolu CHEN, Hui ZHANG. The Determination of Genotoxic Impurities Dimethyl Sulfate and Diethyl Sulfate in Finerenone by UPLC-MS/MS[J]. Pharmacy Today, 2026 , 36 (3) : 175 -178 . DOI: 10.12048/j.issn.1674-229X.2026.03.003
Appendix
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Year 2026 volume 36 Issue 3
131
41
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Article Info
doi: 10.12048/j.issn.1674-229X.2026.03.003
  • Receive Date：2025-09-09
  • Online Date：2026-09-23
  • Published：2026-03-25
Article Data
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History
  • Received：2025-09-09
Funding
Affiliations
    1.Jiangxi Xincheng Pharmaceutical Co., Ltd., Yichun, Jiangxi 336000, China
    2.The People' s Hospital of Dongxiang, Fuzhou, Jiangxi 331800, China
    3.Taizhou Vocational College of Science and Technology, Taizhou, Zhejiang 318020, China
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https://castjournals.cast.org.cn/joweb/jryx/EN/10.12048/j.issn.1674-229X.2026.03.003
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表12种不同金属材料的力学参数
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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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