多西他赛注射液在注射液用局部覆聚四氟乙烯膜溴化丁基橡胶塞中棕榈酸及硬脂酸迁移量的测定  

Determination of palmitic acid and stearic acid migration of docetaxel injection in brominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injection

作　　者：王悦雯 刘言 Wang Yuewen;Liu Yan(Tianjin Institute of Drug Control and Research,Tianjin 300070)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《天津药学》2024年第1期14-17,共4页Tianjin Pharmacy

摘　　要：目的:建立多西他赛注射液与注射液用局部覆聚四氟乙烯膜溴化丁基橡胶塞相容性研究中棕榈酸及硬脂酸迁移量的气相色谱分析方法。方法:采用DB-FFAP色谱柱,采用程序升温:170℃保持2 min,10℃/min速率升高至240℃,保持11 min,流速:2 ml/min;进样口温度220℃;检测器为FID,温度260℃。结果:棕榈酸甲酯及硬脂酸甲酯分别在0.1959~195.86μg/ml(r=0.9999)、0.1918~191.85μg/ml(r=0.9998)浓度范围内呈良好的线性关系;棕榈酸甲酯及硬脂酸甲酯加样回收率分别为96.66%(RSD为0.42%)和96.53%(RSD为0.45%);棕榈酸甲酯、硬脂酸甲酯的检测限分别为58和98 ng/ml。3批样品5个时间点硬脂酸的迁移量为15.21~26.35μg/ml,棕榈酸的迁移量为12.82~16.26μg/ml。结论:经方法学验证,所建立的方法准确可靠,可用于测定多西他赛注射液在注射液用局部覆聚四氟乙烯膜溴化丁基橡胶塞中棕榈酸和硬脂酸迁移量的测定。Objective:To establish a gas chromatographic method for determining the migration of palmitic acid and stearic acid in the compatibility study of docetaxel injection with topically coated polytetrafluoroethylene film bromobutyl rubber stopper for injection.Methods:A DB-FFAP capillary column was used,with programmed temperature increase:170℃held for 2 min,10℃/min rate increase to 240℃,held for 11 min.The flow rate was 2 ml/min.The inlet temperature was 220℃,and the FID detector temperature was 260℃.Results:Methyl palmitate and methyl stearate showed good linearity in the concentration ranges of 0.1959~195.86μg/ml(r=0.9999)and 0.1918~191.85μg/ml(r=0.9998),respectively;the spiked recoveries were 96.66%(RSD was 0.42%)and 96.53%(RSD was 0.42%)for methyl palmitate and methyl stearate,respectively.The detection limits for methyl palmitate and methyl stearate were 58 and 98 ng/ml,respectively.The migration of stearic acid and palmitic acid at five time points in three batches of samples ranged from 15.21 to 26.35μg/ml and 12.82 to 16.26μg/ml,respectively.Conclusion:The method is accurate and reliable and can be used to determine the migration of palmitic acid and stearic acid of docetaxel injection in brominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injection.

关 键 词：多西他赛注射液 注射液用局部覆聚四氟乙烯膜溴化丁基橡胶塞 棕榈酸 硬脂酸 棕榈酸甲酯 硬脂酸甲酯 迁移量 气相色谱法 

分 类 号：R917[医药卫生—药物分析学]