基于LC-MS法对不同提取条件下生物反应袋中bDtBPP含量分析

Analysis for bDtBPP Content of SUBs in Different Extraction with LC-MS

建立LC-MS测定一次性生物反应袋中双(2,4-双叔丁基苯基)磷酸酯(bDtBPP)含量的方法。采用C18-AR色谱柱(4.6 mm×150 mm,3μm);流动相A为0.05%(体积比)氨水溶液,B为0.05%(体积比)氨水甲醇,流速0.5 mL/min,柱温40℃,进样量5μL。线性范围在0.13~20.16μg/mL,回收率在93.7%~108.3%,精密度和稳定性RSD小于5.0%。本研究建立的LC-MS方法简单,准确,可靠,为测定一次性生物反应袋中bDtBPP含量提供参考依据,为生物制药过程中一次性使用系统的选择和质量控制提供了重要参考。

A LC-MS method was established for the content of bDtBPP which was extracted from SUBs.The samples were separated on C 18-AR column(4.6 mm×150 mm,3μm)with mobile phase A of 0.05%(volume ratio)ammonia water solution and B of 0.05%(volume ratio)ammonia water methanol,using gradient elution method.Flow rate was 0.5 mL/min,column temperature was 40℃,injection volume was 5μL.The linear range was 0.13~20.16μg/mL.The average recoveries were all in a range of 93.7%~108.3%,RSD of precision and solution stability RSD were less than 5.0%.LC-MS method was simple,accurate and reliable,it could provide a reference for determination of bDtBPP content in SUBs,and provide an important reference for the selection and quality control of SUBs.