知识与财富的链接
目的:对洛索洛芬钠片的有关物质检测方法进行优化,提高杂质分离度和检出率。方法:采用Intersil ODS-3(4.6 mm×250 mm, 5μm);流动相为0.01 mol·L-1的磷酸二氢钾溶液(pH 4.5)-乙腈(85∶15)(A)和0.01 mol·L-1的磷酸二氢钾溶液(pH 4.5)-乙腈(15∶85)(B),梯度洗脱,流速1.0 mL·min-1;检测波长220 nm;柱温40℃;进样体积20μL。结果:洛索洛芬钠与相邻杂质以及5个已知杂质之间均达到的分离、洛索洛芬钠和5个已知杂质的浓度与峰面积之间线性关系(r>0.999 9)、精密度、准确度和耐用性均良好;洛索洛芬钠片3批自制制剂与3批参比制剂的杂质谱基本一致,各批样品均符合制订质量标准的规定。结论:本法可用于洛索洛芬钠片有关物质的质量控制。
[Objective]：An HPLC method was established for the simultaneous determination of five known impurities in loxoprofen sodium tablets. [Method]：Intersil ODS-3(4.6×250 mm,5 μm)was used;Mobile phase:0.01 mol﹒L-1potassium dihydrogen phosphate solution (pH4.5) - acetonitrile (85:15) (A) and 0.01 mol﹒L-1 potassium dihydrogen phosphate solution (pH4.5) - acetonitrile (15:85) (B),gradient elution;Flow rate：1.0mL.min-1;Detection wavelength: 220nm;Column temperature：40℃; Injection volume：20μL。 [Result]：The established method had good specificity, satisfactory interference, and there was a good separation between Loxoprofen Sodium and adjacent impurity and known impurity. The linear relationship between concentration and corresponding peak area of Loxoprofen Sodium and all related substances were ideal (r > 0.9999). The precision, accuracy, and durability of this method were fine. The impurity spectra of 3 batches of self-made preparations and 3 batches of reference preparations of Loxoprofen Sodium Tablets were basically consistent, complying with the established quality standards.[Conclusion]：The method is specific,Sensitive,accurate and repeatable. It can be suitable for the determination of related substances in Loxoprofen Sodium Tablets.
