反相高效液相色谱法测定硝酸毛果芸香碱滴眼液的含量和有关物质  

RP-HPLC determination of content and related substances of pilocarpine nitrate eye drops

作　　者：王伟[1,2] 宁洪鑫[2] 杨颖[2] 

机构地区：[1]天津医科大学,天津300070 [2]天津药物研究院,天津300193

出　　处：《药物分析杂志》2011年第11期2139-2142,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立一种反相高效液相色谱法测定硝酸毛果芸香碱滴眼液的含量和有关物质。方法:用迪马ODS柱(4.6 mm×250 mm,5μm),甲醇-缓冲液(取磷酸13.5 mL,加水700 mL、三乙胺3 mL,加水稀释至1000 mL,用20%氢氧化钠溶液调节pH值至3.00±0.02)(80∶920)为流动相;流速为1.0 mL.min-1;柱温为30℃;UV检测波长220 nm。结果:该色谱条件下,毛果芸香碱与各杂质之间分离良好。毛果芸香碱在2-7μg.mL-1(r=0.9992)、50-350μg.mL-1(r=0.9996)范围内,线性关系良好;含量测定精密度试验RSD=0.50%(n=6);平均回收率为100.5%(n=9);有关物质精密度试验RSD=0.54%(n=6)。结论:本方法简便、快捷、准确、灵敏,可有效控制产品质量。Objective： To establish an RP - HPLC method of determination for content and its related substances of pilocarpine nitrate eye drops. Methods：Employed Dikma ODS column（4. 6 mm × 250 mm ,5 μm）, methanol -buffer solution （ 80： 920）, buffer solution is H3 PO413.5 mL, diluted to 700 mL water, add 3 mL triethylamine, and dilute with water to 1000 mL, adjust with 20% sodium hydroxide to a pH of 3.00 ± 0. 02 ,flow rate：1. 0 mL/min, column temperature ：30℃, ultraviolet detection wavelength ： 220 nm. Results： Good separation could be achieved between pilocarpine and the related compounds under this chromatographic system. The calibration curve of pilocarpine was linear in the concentration range of 2 - 7 μg · mL^- 1 （ r = 0. 9992） and 50 - 350 μg · mL^- 1 （ r = 0. 9996 ） , The precision of content and its related substances of pilocarpine was good and the RSD was 0. 50% （ n = 6） and 0.54% （ n = 6） respectively,The average recovery（n = 9）was 100. 5%. Conclusion：The method is simple,rapid, accurate and sensitive , which can be used to control the quality of products effectively.

关 键 词：眼科用药 硝酸毛果芸香碱 反相高效液相色谱法 含量 有关物质 杂质检测 毛果芸香酸 异毛果芸盾碱 异毛果云香酸 

分 类 号：R917[医药卫生—药物分析学]