Development and validation of a capillary zone electrophoresis method for the simultaneous analysis of clarithromycin, omeprazole, and tinidazole in pharmaceutical formulations

Abstract

Triple therapy consisting of three active ingredients, namely, omeprazole, clarithromycin, and tinidazole, has been reported to be extremely effective against Helicobacter pylori disease. In this study, a fast, simple, and validated capillary zone electrophoresis procedure was developed for the analysis of clarithromycin (CLR), omeprazole (OMP), and tinidazole (TID) in pharmaceutical dosage forms. Separation conditions such as the pH of the background electrolyte (BGE), concentration of BGE, capillary temperature, applied voltage, and injection time were examined. A shorter analysis time of less than 7 minutes was achieved with a BGE consisting of 50 mM phosphate buffer at pH 4.5, an applied voltage of 22 kV, a capillary temperature of 25 °C and an injection time of 7 s at a detection wavelength of 230 nm. The procedure was validated with regards to linearity and limits of detection and quantification, intra-day and inter-day precisions and accuracy. Excellent linearity was obtained in concentration ranges of 60–250, 5–60, and 80–250 μg mL⁻¹ for CLR, OMP, and TID, respectively. The limits of detection (LODs) and limits of quantification (LOQs) for CLR, OMP and TID were 45, 3.5 and 62 μg mL⁻¹ and 0.54, 4.7 and 0.74 μg mL⁻¹, respectively. Notably, this procedure was used for the analysis of CLR, OMP and TID in merged- and single-tablet pharmaceutical formulations.