多巴丝肼胶囊有关物质的HPLC法测定.pdfVIP

• 564 • 中国医药工业杂志 Chinese Journal of Pharmaceuticals 2014 , 45 (6) 多巴丝月井胶囊有关物质的 HPLC 法测定 刘广娟，孙宁云，陈秋芬，张军东* (上海信谊药厂有限公司药物研究所，上海 201206) 摘要:建立了高效液相色谱法测定多巴丝阱胶囊中盐酸苇丝脐的有关物质。采用 Merck Purospher star RP-C 色谱柱，流 8 5.95 mg/ml 磷酸二氢饵溶液(含笑烧磺酸纳溶液 1.525 mg/ml)乙腊 (79 : 21). 用磷酸调至 pH 3.5 ，检测波长 动相为 220 nmo 结果显示样品中的有关物质均能检出。盐酸韦丝月井、有关物质 A 和 B 分别在 0.25 ~ 50、1.2 ~ 30 和 0.15 ~ 50μg/m1 浓度范围内线性关系良好。有关物质 A、 B、 C 的平均回收率分别为99.7% 、 108.5%和 102.5% .RSD 分别为 5 .40% 、 2.89%和 3.14% 。 关键词:多巴丝脐胶囊:盐酸韦丝脐;有关物质:高效液相色谱;测定 中图分类号: TQ460.γ2 ， 0657.T2 文献标志码:A 文章编号: 1001-8255 (2014) 06-0564-03 Determination of Related Substances In Levodopa and Benserazide Hydrochloride Capsules by HPLC LIU Guangjuan , SUN Ningyun , CHEN Qiufen, ZHANG Jundong* (RD Center, Sine Pharmaceutical Lab. , Shanghai 201206) ABSTRACT: An HPLC method was established for the detennination of the related substances in levodopa and benserazide hydrochloride capsules. A Merck Purospher star RP-C 8 column was used , with the mobile phase of 5.95 mg/ml potassium dihydrogen phosphate solution (containing 1.525 mg/ml sodium decanesulfonate) : acetonitrile (79 : 2 1), adjusted to pH 3.5 with phosphoric acid , at the detection wavelength of 220 nm. The resolution between the peaks of benserazide hydrochloride and related substances was good. The calibration curves for benserazide hydrochloride , related substances A and B were linear in the concentration ranges of 0.25 - 50, 1.2 - 30 and 0.15 - 50μg/ml. The average recoveries of related substances A , B and C were 99.7