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机构地区:[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
出 处:《中国医药工业杂志》2016年第4期459-463,共5页Chinese Journal of Pharmaceuticals
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,以乙腈∶25 mmol/L磷酸二氢钾溶液(用磷酸调至pH 2.2)(42∶58)为流动相,检测波长254 nm。双醋瑞因及其有关物质(除七乙酰芦荟苷)在0.2~3.0mg/ml范围内线性关系良好,七乙酰芦荟苷在0.6~3.0mg/ml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%。An HPLC method was established for the determination of the nine related substances in diacere. A Phenomenex prodigy 100 A ODS3 column was used with the mobile phase of acetonitrile∶25 mmol/L potassium dihydrogen phosphate solution(adjusted to p H 2.2 with phosphoric acid)(42∶58), at the detection wavelength of 254 nm. It was linear for diacerein and its related substances(except heptaacetyl barbaloin) in the range of 0.2 — 3.0 μg/ml. As for heptaacetyl barbaloin, the linear range was 0.6 — 3.0 μg/ml. The average recoveries of the related substances were 96.8%— 99.9%, with RSDs of 1.7%— 3.5%.
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