伊潘立酮片有关物质一致性评价研究  

Evaluation of related substances in Iloperidone Tablets

作　　者：米楠 房思萌 华东东 臧可昕 MI Nan;FANG Simeng;HUA Dongdong;ZANG Kexin(Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193)

机构地区：[1]天津药物研究院有限公司制剂中心,天津300193 [2]天津药物研究院有限公司释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物评价研究》2018年第11期2015-2020,共6页Drug Evaluation Research

摘　　要：目的建立伊潘立酮片的有关物质测定方法,与参比制剂进行有关物质一致性评价研究。方法建立高效液相色谱法(HPLC)测定伊潘立酮片有关物质,并考察方法的专属性、线性、精密度、准确性及耐用性等。采用Agela Venusil MP C18(150 mm×4.6 mm,5μm)色谱柱,以0.02 mol/L磷酸氢二铵缓冲液(磷酸调pH至7.0±0.1)为流动相A,以乙腈为流动相B,体积流量1.0 mL/min,检测波长为229 nm,柱温40℃。结果在选定的色谱条件下,伊潘立酮与杂质分离良好,辅料无干扰。自研伊潘立酮片与参比制剂杂质谱相似。结论该方法准确、可靠、耐用性好,自研伊潘立酮片与参比制剂具有有关物质一致性。Objective To establish high performance liquid chromatography(HPLC) methods for determination of related substances in Iloperidone tablets.Methods The related substances were determined on a Agela Venusil MP C18 column(150 mm × 4.6 mm, 5μm), Mobile phase A: 0.02 mol/L diammonium hydrogen phosphate buffer(adjust pH value to 7.0 with phosphoric acid), mobile phase B: acetonitrile, The flow rate was 1.0 ml/min and the detection wavelength was 229 nm, column temperature was 40℃.Results Under the chromatographic conditions, the resolution of Iloperidone and related substances was great, and excipients without interference. The related substances of reference preparation and self-preparation have significant similarity. Conclusion The method is accurate, reliable and durable, and the related substances of the two preparations are similar.

关 键 词：伊潘立酮片 有关物质 一致性 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]