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 µg·mL⁻¹ for methyl hexadecanoate and 1.00–20.00 µg·mL⁻¹ for methyl stearate, with the limits of detection (LOD) 11.94 ng·mL⁻¹ and 11.90 ng·mL⁻¹, 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.

中文翻译：

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甲基酯化与气相色谱-质谱联用（GC-MS）用于测定润滑剂含量，以评估脂质体注射剂与氯化丁基橡胶塞的相容性。

为了评估相容性，开发了一种简单，灵敏且精确的甲基酯化方法，并结合气相色谱-质谱（GC-MS）方法确定氯化丁基橡胶塞和脂质体注射液中棕榈酸和硬脂酸的含量。药品包装材料。在该实验中，在氯化丁基橡胶塞和脂质体注射剂中检测出棕榈酸和硬脂酸的形式为十六烷酸甲酯和硬脂酸甲酯。结果显示良好的线性在0.50-10.00范围 μ克·ML ^-1为十六烷酸甲酯和1.00-20.00  μ克·ML ^-1为硬脂酸甲酯，与检测限（LOD）11.94纳克·ML ^-1和分别为11.90 ng·mL ^-1。回收率在95.25％至100.29％之间，相对标准偏差（RSD）不超过7.16％。所开发的方法已成功地用于评估氯化丁基橡胶塞与脂质体注射剂的相容性和安全性评估。