HPLC法测定布洛芬钠有关物质

Determination of the related substances in ibuprofen sodium by HPLC

目的采用高效液相色谱法测定布洛芬钠有关物质。方法仪器:高效液相色谱仪(紫外检测器);色谱柱:Supelco discovery C18(4.0 mm×150 mm,5μm);流动相:水(用H3PO4调pH为2.5)-乙腈(66∶34);检测波长:214 nm;柱温:(30±0.5)℃;流速:2 mL·min-1;进样体积:5μL。结果布洛芬钠主峰与杂质B主峰分离度为3.0,分离良好;布洛芬钠盐检测限为0.100 6μg·mL-1,定量限为0.503μg·mL-1;杂质B检测限为0.06μg·mL-1,定量限为0.24μg·mL-1;精密度:样品杂质含量测试结果的RSD=0<2.0%。结论该方法灵敏、简单、准确,适用于布洛芬钠有关物质的测定。

Objective To establish an HpLC method for the determination of the related substances in ibuprofen sodium. Methods Instrument：HpLC（UV detector）,column：Supelco discovery C18（4. 0 mm ×150 mm,5 μm）,mobile phase：water（adjusted pH to 2. 5 with phosphoric acid）-acetonitrile（66：34）,the detection wavelength was 214 nm,the column temperature was（30 ± 0. 5）℃;The flow rate was 2 mL·min^-1 and the inject volume was 5μL. Results The main peak of ibuprofen sodium was separated from impurity B completely,the resolution was 3. 0;The limit of detection（ LOD）of ibuprofen sodium was 0. 100 6μg·mL^-1 ,and its limit of quantitation（ LOQ）was 0. 503μg·mL^-1;The LOD of impurity B was 0. 06 μg·mL-1 ,and its LOQ was 0. 24 μg·mL-1;precision：the RSD of test results of sample impurities was 0〈2. 0%. Conclusion The method was highly selective,simple and accurate,and was suitable for the determination of related substances in ibuprofen sodium.