盐酸米托蒽醌有关物质测定的3种标准方法比较

A Comparative Research on Three Standard Testing Methods of Relative Substance in Mitoxantrone Hydrochloride

目的比较研究测定盐酸米托蒽醌有关物质的3种标准测定方法。方法这3种方法分别收载于美国药典(USP24-32)、中国药典(2000,2005年版二部)和国家药品标准犤WS1-(X-038)-2002Z和WS1-(X-040)-2002Z犦中。美国药典和国家药品标准方法采用高效液相色谱法,色谱柱分别为μBondapakTMPhenyl(300mm×3.9mm,10μm,125?)和PromosilC18(250mm×4.6mm,5μm,100?),流动相为水-乙腈-庚烷磺酸钠溶液。结果国家药品标准中的高效液相色谱(HPLC)法测定盐酸米托蒽醌有关物质优于美国药典和中国药典方法。结论建议测定盐酸米托蒽醌有关物质时推广使用国家药品标准中的高效液相色谱法。

Objective To study on the three standard testing methods of relative substance in mixtoxantrone hydrochloride.Methods The relative substance was determined using the standard testing methods of USP 24-32,Chinese Pharmacopoeia （edition 2000 and 2005,part Ⅱ）,and the standard of national drug [WS1-（X-038）-2002Z,WS1-（X-040）-2002Z],respectively.High Performance Liquid Chromatography （HPLC） method was adopted in USP and National Drug Standards.The μBondapak^TM Phenyl（300 mm×3.9 mm,10 μm,125 A）and Promosil C18 column（250 mm×4.6 mm,5 μm,100A） were used respectively.The mobile phase was water-acetonitrile-heptanesulfonate sodium.Results The result indicated that the HPLC methods of the standard of national drug was the best one,compared with the methods of USP and Chinese Pharmacopoeia.Conclusion To ensure better quality control for the products,it is indicated that the relative substance is controlled widely by the methods of the standard of national drug.