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在眼科产品常见的pH值下进行热灭菌时,依地酸二钠对硝酸苯汞的化学降解作用。

The chemical degradation of phenylmercuric nitrate by disodium edetate during heat sterilization at pH values commonly encountered in ophthalmic products.

作者信息

Parkin J E, Duffy M B, Loo C N

机构信息

School of Pharmacy, Curtin University of Technology, Bentley, Western Australia.

出版信息

J Clin Pharm Ther. 1992 Oct;17(5):307-14. doi: 10.1111/j.1365-2710.1992.tb01309.x.

DOI:10.1111/j.1365-2710.1992.tb01309.x
PMID:1464635
Abstract

The stability following heat sterilization (121 degrees C for 15 min) of phenylmercuric (PM) nitrate in the presence of disodium edetate at pH values 5-8 has been investigated by both high-performance liquid chromatography (HPLC) and atomic absorption spectroscopy (AAS). A stability-indicating HPLC method involving formation of the diethylamine-dithiocarbamate complexes of phenylmercuric and mercuric ions was found to suffer a pH-dependent interference from disodium edetate. A second method was therefore also employed involving selective extraction into diethylether of the phenylmercuric ion followed by HPLC of the piperidinedithiocarbamate complex with concomitant analysis of the unextracted mercuric ion by AAS using the cold-vapour technique. An HPLC method was also developed for benzene in the degraded mixtures. The application of these methods to autoclaved solutions containing PM nitrate and disodium edetate demonstrates that under the conditions of heat sterilization the phenylmercuric ion is degraded to mercuric ion and benzene to the extent of 15% at pH 8, 80% at pH 7 and completely degraded at pH 5 and 6.

摘要

通过高效液相色谱法(HPLC)和原子吸收光谱法(AAS)研究了在pH值为5 - 8时,硝酸苯汞(PM)在乙二胺四乙酸二钠存在下经热灭菌(121℃,15分钟)后的稳定性。一种稳定性指示HPLC方法,该方法涉及形成苯汞离子和汞离子的二乙胺二硫代氨基甲酸盐络合物,发现该方法受到乙二胺四乙酸二钠的pH依赖性干扰。因此还采用了第二种方法,即先将苯汞离子选择性萃取到二乙醚中,然后对哌啶二硫代氨基甲酸盐络合物进行HPLC分析,同时使用冷蒸气技术通过AAS对未萃取的汞离子进行分析。还开发了一种用于分析降解混合物中苯的HPLC方法。将这些方法应用于含有硝酸PM和乙二胺四乙酸二钠的高压灭菌溶液,结果表明,在热灭菌条件下,苯汞离子会降解为汞离子,苯在pH 8时降解程度为15%,在pH 7时降解程度为80%,在pH 5和6时完全降解。

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