硝酸毛果芸香碱滴眼液中苯扎氯铵含量测定

目的:用高效液相色谱法(HPLC)测定硝酸毛果芸香碱滴眼液中苯扎氯铵的含量。方法:色谱柱为CN(HypersilCN,150mm×4.6mm,5μm);流动相为0.03mol/L磷酸二氢钠溶液(用1mol/L氢氧化钠溶液调节pH至7.0)-乙腈(57:43);流速为2mL/min;检测波长为214nm;柱温为35℃;苯扎氯铵C12、C14、C16之间的分离度应符合规定。结果:苯扎氯铵在40～160μg/mL内线性关系良好,Y=12.2281X+6.8814(r=0.9999,n=6),回收率为99.7%～101.9%,RSD=0.66%。结论:该法操作简便,快速、准确、灵敏度高,重复性好,可用于硝酸毛果芸香碱滴眼液中苯扎氯铵的含量测定。

Determination of Benzalkonium Chloride in Pilocarpine Nitrate Eye Drops

Objective： To determine the content of benzalkonium chloride in the pilocarpine nitrate eye drops by HPLC. Methods： The chromatographic column （Hypersil CN,150 mm ×4.6 mm, 5 μm） was used, the mobile phase was 0.03 mol/L sodium dihydrogen phosphate solution （plus 1 mol/L sodium hydroxide solution adjusted pH value to 7.0）- acetonitrile （57：43）, the flow rate was 2.0 mL/min, the UV detection was at 214 nm, the column temperature was 35 ℃, the resolutions between benzalkonium chloride C12, C14, Cl6 conformed to the stipulation. Results ： The linear calibration curves ofbenzalkonium chloride were obtained within the range of 40 - 160μg/mL, Y = 12.228 1 X ＋ 6.881 4 （r = 0.999 9, n = 6）, the recovery was 99.7% - 101.9% （RSD = 0.66%）. Conclusion：The method is simple, fast and accurate, with a high sensitivity and good repeatability, and can be used for the content determination of benzalkonium chloride in the pilocarpine nitrate eye drops.