Abstract
A reversed phase high performance liquid chromatography (RP‐HPLC) method was developed, validated and used for the quantitative determination of rabeprazole sodium (RP) and itopride hydrochloride (IH), from its tablet dosage form. Chromatographic separation was performed on a Phenomenex C18 column (250 mm × 4.6 mm, 5 μm), with a mobile phase comprising of a mixture of 50 mM ammonium acetate buffer and methanol (20:80v/v), pH 4.5 adjusted with acetic acid, at a flow rate of 1.3 mL/min with detection at 286 nm. Separation was completed in less than 10 min. As per International Conference on Harmonization (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation and limit of detection. Linearity of RP was found to be in the range of 37.5‐375 μg/mL and IH was found to be in the range of 5‐50 μg/mL. The correlation coefficients were 0.9997 and 0.9995 for RB and IH respectively. The accuracy of the developed method was found to be 98.6‐100.7 for RP and 99.42 ‐100.81 for IH. The experiment shows the developed method is free from interference of excipients. It indicates the developed RP‐HPLC method is simple, linear, precise and accurate and it can be conveniently adopted for the routine quality control analysis of the tablet dosage form.
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