RP-HPLC法测定羟苯磺酸钙分散片中的有关物质  

Determination of Related Substances of Calcium Dobsilate by RP-HPLC

作　　者：王静[1] 林志立[2] 吴建伟 

机构地区：[1]江苏省药物研究所,南京210009 [2]莆田学院,莆田351100 [3]浙江莎普爱思制药有限公司,平湖314200

出　　处：《江苏药学与临床研究》2006年第6期384-386,共3页Jiangsu Pharmacertical and Clinical Research

摘　　要：目的建立反相高效液相色谱法测定羟苯磺酸钙分散片中的有关物质。方法色谱柱为Hypersil C6H5柱,流动相:0.5 mol.L-1磷酸二氢钠溶液-甲醇-三乙胺(100∶5∶0.02);流速为1.0 ml.min-1;测定波长为301 nm。结果不仅能够测定原料中杂质对苯二酚,还能够与破坏性试验产生的降解产物有效分离。结论该法简便、准确、结果可靠。AIM To develop a RP-HPLC method for the determination of related substances and degradation subtances of calcium dobsilate.METHODS Chromatographic conditions were as follows： Column： Hypersil C6H5, the mobile phase was composed of 0.5 mol· L^- 1 NaH2PO3 buffer-methanol-cyclo hexyl amine（100 ： 5 ： 0.02） with the flow rate of 1.0 ml· min^- 1, the detective wavelength： 289 nm. RESULTS The impurity and degradation products were detenninged. CONCLUSION The method is convenient,accurate and the results is reliabel.

关 键 词：反相高效液相色谱法 羟苯磺酸钙 对苯二酚 有关物质 

分 类 号：R927.2[医药卫生—药学]