Determination of the related substances in ibuprofen sodium by HPLC
QI Yong
NIE Lei
Abstract:Objective To establish an HPLC method for the determination of the related substances in ibuProfen sodi-um. 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.
Keywords:HPLCIbuProfen sodiumRelated substances
Publication Date:2014-01-01
Online Publishing Date:2025-08-15(First online date of this platform, not the publication date of the document)
Pages:3( 446-448 )
