硝酸毛果芸香碱滴眼液中苯扎氯铵含量测定  

Determination of Benzalkonium Chloride in Pilocarpine Nitrate Eye Drops

作　　者：黄志元 朱样根 

机构地区：[1]江西珍视明药业有限公司,江西抚州344000

出　　处：《中国执业药师》2012年第10期25-28,41,共5页China Licensed Pharmacist

摘　　要：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。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.

关 键 词：高效液相色谱法 苯扎氯铵 硝酸毛果芸香碱滴眼液 含量测定 

分 类 号：R988.1[医药卫生—药品]