ポスター発表
- 第2日 5月16日（火） P会場（ホワイエ，会議室1004-1007）
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2P-49 PDF
高感度化されたタンデム四重極質量分析計によるメトホルミン中のニトロソアミン定量
Nitrosamine impurities are considered probable human carcinogens or compounds that can cause cancer.1,2 Since 2018, the discovery of nitrosamines in several marketed medicines resulted in disruptive product recalls. 3,4 Liquid chromatography-mass spectrometry (LC-MS) instrumentation have successfully been employed for the accurate identification and quantification of low-level nitrosamines in various pharmaceutical products.5,6 The development and performance of an UPLC™ method with tandem quadrupole mass spectrometer for the detection and quantification of nine nitrosamine impurities (NDMA, NDEA, NEIPA, NMOR, NDIPA, NDPA, NMPA, NMBA, NDBA) in metformin drug substance. The method demonstrated excellent quantitative performance reaching LOQ limits of 0.01 to 0.1 ng/mL in neat solvent and 0.025 to 0.1 ng/mL in 20 mg/mL metformin drug substance, respectively. The accuracy of nitrosamines in metformin drug substance resulted in recovery of 85 to 110%, respectively. The described UPLC-MS/MS method offers highly sensitive, specific, and accurate analysis of nitrosamines in metformin drug substance, enabling fit-for-purpose accurate monitoring of nitrosamines at residual levels that are critical product quality and safety. The system has the performance to meet regulations that are becoming stricter day by day.