Xiong Shan, Deng Zhipeng, Sun Peilu, Mu Yanling, Xue Mingxing
Shandong Academy of Medical Sciences, Institute of Materia Medica, Jinan 250062, People's Republic of China; Key Laboratory for Biotech-Drugs Ministry of Health, Jinan 250062, People's Republic of China; Key Laboratory for Rare & Uncommon Diseases of Shandong Province, Jinan 250062, People's Republic of China.
Shandong Yantong Pharmaceutical Technology Co. Ltd, Jinan 250101, People's Republic of China.
J AOAC Int. 2017 Nov 1;100(6):1771-1775. doi: 10.5740/jaoacint.16-0362. Epub 2017 May 22.
Osimertinib is a new-generation epidermal growth factor inhibitor for the treatment of non-small cell lung cancer. In the present study, a rapid and sensitive LC with tandem MS method was developed and validated for the determination of osimertinib in rat plasma. Chromatographic separation was carried out on a C18 column using acetonitrile and water containing 0.1% formic acid. The assay was validated over a concentration range of 1.0-1000 ng/mL for osimertinib, with a lower LOQ of 1.0 ng/mL. The intra- and interday accuracy values for osimertinib ranged from 92.66 to 101.50% and from 97.08 to 99.15%, respectively, and the intra- and interday precision values for osimertinib ranged from 6.25 to 10.34% and from 3.43 to 10.44%, respectively. The method was successfully applied in a pharmacokinetic study of osimertinib after oral administration of osimertinib (4.5 mg/kg) to rats.
奥希替尼是一种用于治疗非小细胞肺癌的新一代表皮生长因子抑制剂。在本研究中，开发并验证了一种快速灵敏的液相色谱串联质谱法，用于测定大鼠血浆中的奥希替尼。采用含0.1%甲酸的乙腈和水在C18柱上进行色谱分离。该方法在奥希替尼浓度范围为1.0 - 1000 ng/mL内进行了验证，最低定量限为1.0 ng/mL。奥希替尼的日内和日间准确度值分别为92.66%至101.50%和97.08%至99.15%，奥希替尼的日内和日间精密度值分别为6.25%至10.34%和3.43%至10.44%。该方法成功应用于大鼠口服奥希替尼（4.5 mg/kg）后的药代动力学研究。
