西吡氯铵滴眼液中吡啶的测定

Determination of Pyridine in Cetylpyridinium Chloride Ophthalmic Solution

建立西吡氯铵滴眼液中吡啶的气相色谱测定法。方法：用5%二苯基-95%二甲基硅氧烷共聚物为固定相的毛细管柱（30m×0.54mm×5.0μm），柱温在35℃维持5分钟，然后以每分钟8℃的升温速率升至115℃，以氮气为载气，气化室和检测器温度分别为120℃和260℃。结果：吡啶与杂质峰之间的分离良好。在0.492-9.84μg/ml的范围内吡啶的峰面积和浓度线性相关，回收率99.8%（n=9），RSD为4.9%（n=6）。结论：该分析方法准确可靠，简便易行，可用于西吡氯铵滴眼液中吡啶的测定。

Objective： To establish a gas chromatography method for the determination of pyridine in cetylpyridinium chloride ophthalmic solution. Methods： The separation was performed on a capillary column which was a copolymer of 5% diphenyl-95% diphenyl siloxane as stationary phase.Column temperature was 35℃for 5 minutes.Then it increased to 115℃in rate of 8℃per minute.Carrier gas was nitrogen. Injector and detector were set at 120℃and 260℃respectively. Results：Pyridine and contamination could be completely separated with the established method. It was a linear correlation between the peak area and the concentration in concentration range of 0.492-9.84μg/ml.The recovery was 99.8%（n=9）.RSD is 4.9%（n=6）. Conclusion： The established method was accurate, simple and is suitable for determination of pyridine in cetylpyridinium chloride ophthalmic solution.