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A validated HPLC method for the determination of ranitidine in human plasma: Application to bioavailability studies

Reem Al-Swayeh, Syed N.Alvi, Muhammad M.Hammami

A simple and precise reversed-phase high performance liquid chromatography (HPLC) method for the determination of ranitidine in human plasma was developed and validated. Using 4-aminoantipyrene as an internal standard (IS), separationwas achieved on Symmetry Shield RP-18 column. The mobile phase, 0.02Mpotassiumphosphate (dibasic), acetonitrile, andmethanol (80:10:10, v/v) was delivered at a flow rate 1.0 ml/min. The eluent was monitored spectrophotometric at 317 nm. Plasma samples were prepared using centrifree filters. No interference in blank plasma or of commonly used drugs was observed. The relationship between the concentration of ranitidine in plasma and peak area ratio of ranitidine to the ISwas linear over the range of 0.03–2.0 µg/ml. The intra-day and inter-day coefficients of variationwere < 8.0%and < 11.0%, and corresponding biaseswere < 13.4% and < 8.3%, respectively.Mean extraction recovery of ranitidine and IS from plasma samples was 99.4% and 87%, respectively. The method was used to determine ranitidine level in plasma samples obtained from healthy subject and to assess stability of ranitidine in plasma under various conditions encountered in the clinical laboratory.