双氯芬酸钠栓的有关物质方法学研究

目的:建立HPLC法检查双氯芬酸钠栓有关物质的方法。方法:采用Agilent-C8(250mm×4.6mm,5μ);pH2.5的磷酸盐缓冲液(含有0.5g/L的磷酸和0.8g/L的磷酸二氢钠溶液,磷酸调pH2.5)-甲醇(40:60)为流动相;检测波长为254nm,溶剂为70%甲醇。结果:经专属性试验双氯芬酸钠峰与相邻杂质峰分离度良好;杂质A和总杂质均不稳定,因此供试品溶液需临用现配。在pH2.2～2.8范围内及更换色谱柱型号的条件下,本方法仍可有效检测本品的有关物质,说明本方法耐用性较好。结论:本方法简便、快速、可有效检测双氯芬酸钠栓中的有关物质。

Methodology Study of the Related Substances in Diclofenac Sodium Suppository

Objective:To establish a HPLC method for the determination of related substances in Miconazole Njtrate suppository.Methods:The HPLC conditions were as follows:Agilent-C8 column(250mm×4.6mm,5μ);take pH2.5 phosphate buffer(including 0.5g/L phosphoric acid and 0.8g/L sodium dihydrogen phosphate,adjusted by phosphoric acid to pH2.5)-methanol(40:60)as mobile phase;detect wavelength at 254nm and take 70% methanol as solvent.Results:The Diclofenac sodium were separated effectively. impurity A and total impurities are not stable,so prepare test solutions immediately before use. Even if change the chromatographic column type and the pH within 2.2~2.8,related substances of the product can be tested with this method,which shows that the method has good durability.Conclusion:The method is simple and rapid,suitable for the quality control of compounds of diclofenac sodium suppository.