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

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中文摘要：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 0.195 9～195.86 μg/ml(r=0.999 9)、0.191 8～191.85 μg/ml(r=0.999 8)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 15.21～26.35 μg/ml,棕榈酸的迁移量为 12.82～16.26 μg/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.

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

外文摘要：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 0.195 9～195.86 μg/ml(r=0.999 9)and 0.191 8～191.85 μg/ml(r=0.999 8),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 26.35 μg/ml and 12.82 to 16.26 μg/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.

外文关键词：

docetaxel injectionbrominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injectionpalmitic acidstearic acidmethyl palmitatemethyl stearatemigrationgas chromatographic

作者：

王悦雯、刘言

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作者单位：

天津市药品检验研究院,天津 300070

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

出版年：

2024

天津药学

天津市医药集团有限公司天津市药学会

天津药学

影响因子：0.794

ISSN：1006-5687

年,卷(期)：2024.36(1)

参考文献量10