高效液相色谱法测定复方新斯的明滴眼液中甲硫酸新斯的明的含量

• 作 者: 唐琦文 江峰 蒋国胜 邓筱华
• 机 构: 上海市眼病防治中心药剂科,上海市眼病防治中心药剂科,上海市眼病防治中心药剂科,上海市浦东新区人民医院药剂科 上海 200040,上海 200040,上海 200040
• 出 处: 中国药师
• 发表日期: 2006年10期
• 关键词: 复方新斯的明滴眼液 甲硫酸新斯的明 高效液相色谱法

目的:建立复方新斯的明滴眼液中甲硫酸新斯的明的测定方法。方法:采用高效液相色谱法,色谱柱为Komasil C18 (150 mm×4．6 mm,5μm),流动相为庚烷磺酸钠溶液(取庚烷磺酸钠4．04 g,磷酸二氢钠2．72 g溶于1 000 ml水中,加三乙胺1．2 ml,用磷酸调节pH=3．0)-乙腈(82∶18),流速为1．0 ml·min-1,检测波长为260 nm。结果:甲硫酸新斯的明在1．01-9．09μg范围内线性关系良好,r=0．999 9,加样回收率为99．7％,RDS为0．93％。结论:该方法具有简便、准确等优点,可用于本制剂的质量控制。

Objective: To establish a method for the determination of neostigmine methosulfate in compound neostigmine eye drops. Methods: High performance liquid chromatography (HPLC) was performed on a Komasil C18 column (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of heptane sulfonate solution (4.04 g heptane sulfonate, Sodium 2.72 g dissolved in 1000 ml of water, add 1.2 ml of triethylamine, adjusted pH = 3.0 with phosphoric acid - acetonitrile (82:18) at a flow rate of 1.0 ml · min -1, detected The wavelength is 260 nm. Results: Neostigmine methionine showed good linearity in the range of 1.01-9.09 μg with r = 0.999 9, the recovery rate was 99.7% and the RDS was 0.93%. Conclusion: This method is simple, accurate and other advantages, can be used for the quality control of the preparation.