论文部分内容阅读
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 a method for the determination of related substances in 4 nimesulide preparations by ultra-fast liquid chromatography (UFLC). Methods The mobile phase was consisted of Syncronis C18 column (100 mm × 2.1 mm × 1.7 μm) with mobile phase of methanol-acetonitrile-0.1% phosphoric acid solution (ammonia water adjusted to pH 6.5, volume ratio of 45: 15:40) at a flow rate of 0.3 mL / min and a detection wavelength of 230 nm. The suitability of this method was investigated using the system suitability solutions of the European Pharmacopoeia and the Chinese Pharmacopoeia, destructive samples, and blank adjuvants from different manufacturers and dosage forms in China. Results The method has high resolution, specificity and can effectively and rapidly detect the related substances in the nimesulide preparations. The destructive test products have no effect on the determination results. The excipients of different manufacturers and different dosage forms have no effect on the determination results. Conclusion The method is efficient, rapid and suitable for a wide range of applications. It can be used for the determination of nimesulide related substances in different domestic manufacturers and in different dosage forms.