双醋瑞因有关物质的HPLC法测定.pdfVIP

• 459 • 中国医药工业杂志 Chinese Journal of Pharmaceuticals 2016, 47 (4) 双醋瑞因有关物质的 HPLC 法测定 苑洪忠1 ，于文国l ，赵孝先2 ，姚换方l ，赵凯1 ， 3* (1.河北凯盛医药科技有限公司，河北石家庄 050035; 2 河北医科大学第四医院，河北石家庄 050011 ; 3. 江西欧氏药业有限责任公司，江西新余 338004) 摘要:建立了高效液相色谱法测定双醋瑞因的 9 个有关物质。采用 Phenomenex prodigy 100A ODS3 色谱柱，以乙睛: 25 mmol!L磷酸二氢饵溶液(用磷酸调至pH 2.2) (42 : 58) 为流动相，检测波长 254 nmo 双醋瑞因及其有关物质(除七 乙酷芦芸背)在 0.2 ~ 3.0μg/ml 范围内线性关系良好，七乙欧芦芸音在 0.6 ~ 3.0μglml 浓度范围内线性关系良好。有关 物质的平均回收率 96.8%~ 99.9% , RSD 为1.7%~ 3.5% 。 关键词:双醋瑞因:有关物质:高效液相色谱:测定 中图分类号: 0657.r2; TQ460.γ2 文献标志码:A 文章编号: 1001-8255 (2016) 04-0459-05 DOI: 10.1 6522/j.c此i.cjph.2016.04.021 Determination of the Related Substances in Diacerein by HPLC 2 YUAN Hongzhong\ YU Wenguo\ ZHAO Xiaoxian , YAO Huanfang\ ZHAO Ka矿i 1,3 (υ1. He彷bei 缸Kin， 唔gSClαi Pharmaceuticall元èchnoωology Cω0.ι， Lt，以d.， ，劝Shiß归az劝huω4ωan咆!gOω50仰03刃5; 2. The Fourth Hospital 01He呻b如bei Medi比[怡cal 协cfln印iνe旷rsi~沙y， Shijiazhuang 050011; 3. Jiangxi Ourshi Pharmaceutical Co., Ltd. , Xinyu 338004) ABSTRACT: An HPLC method was established for the determination of the nine related substances in diacere. A Phenomenex prodigy 100A ODS3 column was used with the mobile phase of acetonitrile : 25 mmol/L potassium dihydrogen phosphate solution (adjusted to pH 2.2 with phosphoric acid) (42 : 58) , at the detection wavelength of 254 nm. It w臼 linear for diacerein and its related substances (except heptaacetyl barbaloin) in the range ofO .2 - 3.0μg!ml. As for heptaacetyl barbaloin , the linear range was 0.6 - 3.0μg!ml.白白 average recoveries of the related substances were 96.8%- 99.9% , withRSDs of 1.7%- 3.5%. Key