Simultaneous Determination of Famotidine and Flurbiprofen by High Performance Liquid Chromatography

Abstract

Purpose: To develop a selective, sensitive and accurate simultaneous High Performance Liquid Chromatography (HPLC) method for the analysis of flurbiprofen and famotidine tablet dosage form and excipients.

Methods: A simultaneous method for the determination of the two drugs was employed. The assay consisted of isocratic elution of flurbiprofen and famotidine in prepacked Column RT 250-4.6 Purospher® STAR RP-18 end-capped (5 μm), using a mobile phase composed of acetonitrile and phosphate buffer (pH 3.7) in a ratio of 1:1, respectively, as well as an ultraviolet (UV) detector. Flurbiprofen and famotidine were both detected at 265 nm at a flow rate of 1 ml/min following the guidelines of International Conference of Harmonization (ICH).

Results: A sensitive and linear range of 10 to 100 ppm with 0.999 coefficient of correlation for famotidine and flurbiprofen were observed. Blank and placebo showed no interference with the peak retention time of flurbiprofen and famotidine. Recovery of 50 mg famotidine was 99.61 % after 12 h and 99.76 % after 7 days and for flurbiprofen 20 mg it were 99.60 % after 24 h and 99.85 % after 7 days.

Conclusion: Good precision, recovery and accuracy data indicate the reliability of the proposed method. The method may also be suitable for use in bioequivalence studies.

Keywords: Flurbiprofen, Famotidine, Retention time, Limit of detection, Limit of quantification