Development and validation of capillary zone electrophoresis method for simultaneous analysis of clarithromycin, omeprazole, and tinidazole in pharmaceutical dosage form

Abstract

Triple therapy consisted of three active ingredients, omeprazole, clarithromycin, and tinidazole has been reported to be extremely powerful against Helicobacter pylori disease. In this research, 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 form. Separation conditions such as the pH of background electrolyte (BGE), and 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 with a pH of 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 precisionand accuracy. An excellent linearity was obtained in a concentration range between 60-250, 5-60, and 80-250 µg/mL for CLR, OMP, and TID, respectively. The limit of detections (LODs) and limits of quantifications (LOQs) for CLR, OMP and TID were 45, 3.5 and 62 μg/ mL, and 0.54, 4.7 and 0.74 μg/mL, respectively. The presented procedure has been used for the analysis of CLR, OMP and TID in merged and single tablet dosage form.