Cafmeyer N R, Wolfson B B
Daniels Pharmaceuticals, Inc., St. Petersburg, FL 33713.
Am J Hosp Pharm. 1991 Apr;48(4):735-9.
The possible leaching of diethyl phthalate into four currently marketed brands of levothyroxine sodium tablets was investigated. Several strengths of levothyroxine sodium tablets and sizes of containers were used. Samples were analyzed by high-performance liquid chromatography (HPLC) to determine the levothyroxine sodium content and to determine if any unidentified compounds were present. The packaging for the four brands of tablets was also analyzed by using the same HPLC system to determine if any extractable compounds could be detected in the tablets. The potencies of the four brands of tablets were comparable. The tablets from the 100-count container of one brand (brand A) were the only tablets found to contain an unidentified peak in the chromatogram. The desiccants from the bottle showed the same unidentified compound, while the bottle and closure did not yield the peak. Thin-layer chromatography and HPLC identified the peak as diethyl phthalate, a plasticizer in the desiccant. Tablets, bottles, closures, and desiccants for the 1000-count brand A product and all sizes of the other brands were negative for the presence of diethyl phthalate. The desiccants in those containers were from a different manufacturer than the desiccant in the brand A 100-count bottle. Diethyl phthalate in the desiccant in 100-count bottles of brand A levothyroxine sodium tablets appeared to have leached into the tablets.
研究了邻苯二甲酸二乙酯可能向四种市售左甲状腺素钠片中的浸出情况。使用了几种规格的左甲状腺素钠片和不同尺寸的容器。通过高效液相色谱法（HPLC）对样品进行分析，以测定左甲状腺素钠的含量，并确定是否存在任何未知化合物。还使用相同的HPLC系统对这四种品牌片剂的包装进行分析，以确定是否能在片剂中检测到任何可萃取的化合物。这四种品牌片剂的效价相当。在一个品牌（品牌A）100片装容器中的片剂是色谱图中唯一发现含有未知峰的片剂。瓶中的干燥剂显示出相同的未知化合物，而瓶子和瓶盖未出现该峰。薄层色谱法和高效液相色谱法鉴定该峰为邻苯二甲酸二乙酯，是干燥剂中的一种增塑剂。1000片装品牌A产品以及其他品牌所有规格的片剂、瓶子、瓶盖和干燥剂均未检测到邻苯二甲酸二乙酯。这些容器中的干燥剂与品牌A 100片装瓶中的干燥剂来自不同的制造商。品牌A 100片装左甲状腺素钠片干燥剂中的邻苯二甲酸二乙酯似乎已浸出到片剂中。
