高效液相色谱法测定美沙拉嗪控释胶囊的有关物质  

Determination of Related Substances in Mesalamine Extended Release Capsules by HPLC

作　　者：郑小丹[1] 高丽[2] 王锦刚[3] 

机构地区：[1]陕西中医学院 [2]北京科信必成医药科技发展有限公司哈尔滨分公司 [3]北京科信必成医药科技发展有限公司

出　　处：《黑龙江医药》2012年第3期375-378,共4页Heilongjiang Medicine journal

基　　金：国家"十二五"重大新药创制计划"创新型口服药物制剂中试及产业化技术基地"课题(编号:2011ZX09401-018)中的项目

摘　　要：目的:建立一种高效液相色谱法测定美沙拉嗪缓释胶囊的3-氨基水杨酸等有关物质。方法:采用HPLC法。色谱柱为Thermo BDS C8柱(4.6mm×250mm,5μm)。流动相为磷酸盐缓冲液(取磷酸二氢钾1.36g和辛烷磺酸钠2.2g,加水溶解至890ml,用磷酸调节pH至2.2)-甲醇-乙腈(890:80:30),柱温30℃,流速1.2ml·min-1,检测波长为220nm。结果:3-氨基水杨酸在0.1994～1.994μg/mL浓度范围内与峰面积呈良好线性关系,r=1.0000。平均回收率96.38%,RSD为1.71%;定量限为86.69ng/ml。结论:本方法简便、灵敏、准确,能用于美沙拉嗪缓释胶囊有关物质的质量控制。Objectlve：To establish a HPLC method for the determination of the 3 - aminosalicylic acid related substance of mesalamine. Methods：The HPLC was carried out with Thermo BDS C8 （4. 6mm×250mm,5μm） column and Phosphate Buffer Dissolve 1.36g of monobasic potassium phosphate and 2.2g of sodium 1 - octanesulfonate in 890 ml of water and ad- just with phosphoric acid to a pH of 2.2 - methanol - acetonitrile（ 890 ：R0：30） as the mobile phase were used. The tempera- ture of the column was 30℃ ,and the flow rate was 1.2 ml·min-1. The detection wavelength was 220nm. Results：3 - amin- osalieylic acid was 0. 1994-1. 994μg/mL（y= 1. 0000）. The average recovery rate was 96. 38% ,and RSD = 1.71%. Detec- tion limit was 86. 69ng/ml. Conclusion：The proposed method is accurate and sensitive. It is suitable for determination of the related substances of mesalamine.

关 键 词：高效液相色谱法 美沙拉嗪 3-氨基水杨酸 有关物质 

分 类 号：R927.2[医药卫生—药学]