Lehr G J, Yuen S M, Lawrence G D
U.S. Food and Drug Administration, New York Regional Laboratory, Brooklyn 11232, USA.
J AOAC Int. 1995 Mar-Apr;78(2):339-43.
A simple and specific liquid chromatographic method was developed for the determination of atropine in nerve gas antidotes and several other dosage forms. The method is also used simultaneously to quantitate phenol, an antimicrobial agent present in nerve gas antidotes, and to monitor the level of tropic acid, a principal degradation product of atropine. The system uses a Spherisorb CN column and a mobile phase of acetonitrile-0.05M sodium phosphate monobasic (10 + 90), pH 4.0. The detection wavelength is 220 nm. The method was validated by testing for accuracy, linearity, reproducibility and precision. In addition, the proposed method was applied to 8 commercial preparations of atropine, including injectables, ophthalmic solutions, and ointments, and was found to be satisfactory and free from interferences from preservatives, such as benzyl alcohol, methylparaben, benzalkonium chloride and chlorobutanol, that are present in these formulations.
开发了一种简单且特异的液相色谱法，用于测定神经毒气解毒剂及其他几种剂型中的阿托品。该方法还可同时定量神经毒气解毒剂中存在的抗菌剂苯酚，并监测阿托品的主要降解产物托品酸的水平。该系统采用Spherisorb CN柱和乙腈 - 0.05M磷酸二氢钠（10 + 90）、pH 4.0的流动相。检测波长为220 nm。通过准确性、线性、重现性和精密度测试对该方法进行了验证。此外，将所提出的方法应用于8种市售阿托品制剂，包括注射剂、眼药水和软膏，发现该方法令人满意，且不受这些制剂中存在的防腐剂（如苯甲醇、对羟基苯甲酸甲酯、苯扎氯铵和三氯叔丁醇）的干扰。
