RP-HPLC测定明锌素滴眼剂中甲硫酸新斯的明的含量

Determination of neostigmine methylsulfate in Mingxinsu eye drops by RP-HPLC

目的建立了明锌素滴眼剂中甲硫酸新斯的明的含量测定方法方法采用反相高效液相色谱法KromasilC18柱(4.6mm×250mm,5μm),流动相为甲醇-水-冰醋酸-三乙胺(10:90:1:0.5),流速1.0mL·min-1,检测波长260nm,柱温30℃。结果甲硫酸新斯的明在5～50mg·L-1内,峰面积与浓度呈良好线性关系,平均回收率100.2%,RSD=0.7%,n=9结论可用于明锌素滴眼剂中甲硫酸新斯的明质量控制。

OBJECTIVE To establish a HPLC method for the determination of neostigmine methylsulfate in Mingxinsu eye drops. METHODS The separation was performed on a Kromasil C18 column （4.6 mm× 250 mm, 5μm） with methanol-water-glacial acetic acid- triethylamine （ 10 ： 90：1：0.5 ） as mobile phase. The flow rate was 1.0 mL· min^-1 and the detection wavelength was at 260 nm. RESULTS The standard curve was linear over the range of 5 - 50 mg· L^-1 for neostigmine methylsulfate. The average recovery was 100.2% with RSD 0.7 %. CONCLUSION The established method could be used for the quality control of Mingxinsu eye drops.