Abstract
Bioanalytical methods for bioequivalence studies require high sensibility and rapidity due to the large number of samples and the low plasma concentration of drugs. The present study aimed to develop and validate a high-performance liquid chromatography coupled to sequential mass spectrometry (HPLC-MS/MS) method to quantify cimetidine (CMT) in human plasma and to apply it in a bioequivalence study. CMT and the internal standard, ranitidine, were extracted from plasma by liquid-liquid extraction. After extraction, the samples were analysed by HPLC-MS/MS. The chromatographic separation was performed with a C18 column, and the mobile phase was composed of acetonitrile and ammonium acetate buffer 10 mM to which 5% isopropyl alcohol and 0.1% formic acid were added. The recovery of CMT was 67.14% in a linear range from 25 to 6000 ng ml-1. The intraday and interday precision and accuracy were within specified limits. In conclusion, the developed method was precise and accurate and was successfully applied to the bioequivalence study of two formulations of CMT. Key words: Cimetidine, bioequivalence, HPLC-MS/MS, validation.
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