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气相色谱法测定辛酸癸酸聚乙二醇甘油酯的脂肪酸组成
引用本文:赵婧子,周沐野,熊晔蓉,何东升,涂家生. 气相色谱法测定辛酸癸酸聚乙二醇甘油酯的脂肪酸组成[J]. 中国药品标准, 2021, 22(2): 140-145
作者姓名:赵婧子  周沐野  熊晔蓉  何东升  涂家生
作者单位:中国药科大学药学院
基金项目:国家科技重大专项-重大新药创制(No.2017ZX09101001-006-002);国家药典委员会药品标准制修订研究课题(2018Y015)。
摘    要:目的:采用气相色谱法测定药用辅料辛酸癸酸聚乙二醇甘油酯中脂肪酸组成.方法:采用以聚乙二醇-20 mol·L-1为固定液的DB-WAX毛细管柱(30 m×0.53 mm×1.0μm)与氢火焰离子化检测器(FID),柱温初始温度设定为70℃,保持2 min,以每分钟5℃的速率升温至230℃,维持10 min,进样口温度为2...

关 键 词:辛酸癸酸聚乙二醇甘油酯  脂肪酸组成  气相色谱法

Determination of the fatty acid composition in caprylocaproyl polyoxylglycerides by gas chromatography
ZHAO Jingzi,ZHOU Muye,XIONG Yerong,HE Dongsheng,TU Jiasheng. Determination of the fatty acid composition in caprylocaproyl polyoxylglycerides by gas chromatography[J]. , 2021, 22(2): 140-145
Authors:ZHAO Jingzi  ZHOU Muye  XIONG Yerong  HE Dongsheng  TU Jiasheng
Affiliation:(Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs,School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China)
Abstract:Objective:To determine the fatty acid composition in caprylocaproyl polyoxylglycerides by gas chromatography.Methods:The test was performed in a DB-WAX capillary column(30 m×0.53 mm×1.0μm)with polyethylene glycol-20 mol·L-1 as the stationary liquid and a hydrogen flame ionization detector(FID)was used.The temperature program was as follows:setting initial column temperature as 70℃and keeping it for 2 minutes,then increasing to 230℃at a rate of 5℃per minute,and maintaining it for 10 minutes.Both inlet temperature and detector temperature were 250℃,and the split ratio was 5∶1.Results:The GC method was successfully established for the determination of the fatty acid composition in caprylocaproyl polyoxylglycerides.The limit of detection and limit of quantification values of methyl caproate,methyl caprylate,methyl caprate,methyl laurate and methyl myristate were successfully determined,and this established method had the good system suitability,specificity and precision.The fatty acid composition of the three batches of samples were within the reasonable ranges.Conclusion:The established GC method can be used to determine the fatty acid composition in caprylocaproyl polyoxylglycerides,which provides a reference for their quality control and standard establishment.
Keywords:caprylocaproyl polyoxylglycerides  fatty acid composition  gas chromatography
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