ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Microemulsion high performance liquid chromatography method for the determination of ibuprofen in the presence of preservatives and impurities in oral pediatric suspension

Mohamed Debbih, Moulay-Hassane Guermouche, and Saliha Guermouche

Laboratoire de Chromatographie, Faculté de Chimie, USTHB, Alger, Algeria

E-mail: guesali@gmail.com

Abstract: A simple and rapid isocratic oil-in-water microemulsion HPLC method (MELC) has been developed for the analysis of ibuprofen in oral suspension formulation. The method was optimized for simultaneous separation and determination of Ibuprofen and its related compound C (Imp C), sodium benzoate, methylparaben, propylparaben and their related compound A (Imp A). The optimum conditions were achieved by testing several columns and mobile phase compositions, while the chromatographic parameters (retention time, plate number, tailing factor and resolution) were measured. The six compounds were successfully separated within a run time of 14 min, using Eurospher II C18 (150 mm × 4.6 mm i.d., 5 µm) at ambient temperature, a mobile phase made of 5.0 g SDS, 6.6 g butan-1-ol, 0.8 g n-heptane in 100 mL of 0.05% TFA. Flow rate was fixed to 1 mL min⁻¹ and wavelength detection to 254 nm. The same phase was used in UHPLC and monolithic columns. A rapid comparison of system suitability between the three methods was made. The HPLC method was validated following ICH guidelines in terms of selectivity, linearity, accuracy and precision. The developed method was successfully applied to a commercial pharmaceutical formulation which shows that it can be used for routine analysis.

Keywords: Microemulsion; Oil-in-water; HPLC; Complex mixture; Pharmaceutical analysis

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-017-0162-3

Chemical Papers 71 (9) 1693–1703 (2017)