甲酯化结合气相色谱-质谱联用（GC-MS）法测定润滑剂含量以评估氯化丁基橡胶瓶塞与脂质体注射剂的相容性
Methyl Esterification Combined with Gas Chromatography-Mass Spectrometry (GC-MS) for Determining the Contents of Lubricant to Evaluate the Compatibility of Chlorinated Butyl Rubber Stoppers with Liposome Injections.
作者信息
Gao Xun, Chen Kexin, Chi Miaomiao, Qin Kunming
机构信息
School of Pharmacy, Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, Co-Innovation Center of Jiangsu Marine Bio-industry Technology, Jiangsu Ocean University, 59 Cangwu Road Haizhou District, Lianyungang, Jiangsu, China.
出版信息
Int J Anal Chem. 2020 Sep 1;2020:9760580. doi: 10.1155/2020/9760580. eCollection 2020.
A simple, sensitive, and exact methyl esterification in combination with gas chromatography-mass spectrometry (GC-MS) method was developed to determine the contents of palmitic acid and stearic acid in the chlorinated butyl rubber stoppers and liposome injections in order to evaluate the compatibility of pharmaceutical packaging materials. In this experiment, palmitic acid and stearic acid were detected in the form of methyl hexadecanoate and methyl stearate in chlorinated butyl rubber stoppers and liposome injections. The results showed good linearities in the range of 0.50-10.00 g·mL for methyl hexadecanoate and 1.00-20.00 g·mL for methyl stearate, with the limits of detection (LOD) 11.94 ng·mL and 11.90 ng·mL, respectively. The recoveries that ranged from 95.25% to 100.29% were satisfied, and the relative standard deviation (RSD) was no more than 7.16%. The developed method was successfully applied to evaluate the compatibility of chlorinated butyl rubber stoppers with liposome injections and the safety assessment.
建立了一种简单、灵敏且准确的甲酯化结合气相色谱-质谱联用（GC-MS）方法，用于测定氯化丁基橡胶瓶塞和脂质体注射液中棕榈酸和硬脂酸的含量，以评估药用包装材料的相容性。在本实验中，在氯化丁基橡胶瓶塞和脂质体注射液中，棕榈酸和硬脂酸以十六烷酸甲酯和硬脂酸甲酯的形式被检测到。结果表明，十六烷酸甲酯在0.50-10.00 g·mL范围内、硬脂酸甲酯在1.00-20.00 g·mL范围内具有良好的线性关系，检测限（LOD）分别为11.94 ng·mL和11.90 ng·mL。回收率在95.25%至100.29%之间，令人满意，相对标准偏差（RSD）不超过7.16%。所建立的方法成功应用于评估氯化丁基橡胶瓶塞与脂质体注射液的相容性及安全性评价。
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