超快速液相色谱法测定尼美舒利4种制剂中的有关物质

Determination of substances in 4 nimesulide preparations by ultra-fast liquid chromatography

目的建立采用超快速液相色谱(UFLC)法测定4种尼美舒利制剂中有关物质的方法。方法采用岛津超高速液相色谱仪,色谱柱:Syncronis C18柱(100 mm×2.1 mm×1.7μm),流动相:甲醇-乙腈-0.1%磷酸水溶液(氨水调pH至6.5,体积比45∶15∶40),流速为0.3mL/min,检测波长为230nm。分别采用《欧洲药典》和《中国药典》的系统适用性溶液、破坏性样品以及国内不同生产厂家、不同剂型的空白辅料对该方法的适用性进行了考察。结果该方法分辨率高、专属性强,能高效、快速地检测尼美舒利制剂中的有关物质,破坏性试验产物对测定结果没有影响,不同厂家、不同剂型的辅料对测定结果没有影响。结论该方法高效、快速、适用面广,可用于国内不同生产厂家、不同剂型的尼美舒利有关物质的测定。

Objective To establish an ultra-fast liquid chromatography（UFLC）method for detecting the substances in different preparations of nimesulide.Methods Ultra-fast liquid chromatography instruments Shimadzu and Syncronis C18column（100 mm×2.1 mm×1.7μm）were used.The mobile phase was a mixture solvent of methanol-acetonitrile-0.1%solution of orthophosphoric acid（adjusted to pH 6.5with ammonia）（45∶15∶40）.The flowing rate was 0.3mL/min,and the detection wavelength was 230 nm.The system suitability solutions of European Pharmacopoeia and Chinese Pharmacopoeia,the damaging samples and the accessories of different preparations of different manufacturers were used to investigate the method applicability.Results The method had high resolution,strong specificity and can efficiently and quickly detect the related substances in nimesulide preparations.Various degradation products of damaging tests and the accessories of different preparations from different manufacturers had no effect on the determination results.Conclusion The method is efficient,fast,widely applicable and can be used for detecting the substances in different preparations of nimesulide by different manufacturers.