Validated RP-HPLC Method for Estimation of Ranitidine Hydrochloride, Domperidone and Naproxen in Solid Dosage Form

In the present study, a simple, sensitive and specific liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of ranitidine hydrochloride, domperidone and naproxen in solid dosage form. A shim-pack CLC-ODS column (250 mm X 4.6 mm, 5μ and a mobile phase constituting 0.1 M orthophosphoric acid solution (pH 3.0): methanol (35:65 v/v) were used. The flow rate was 1.0 ml/min and detection was carried by using ultraviolet (UV) detector at a wavelength of 280 nm. The retention times of ranitidine hydrochloride, domperidone and naproxen were 2.702 min, 3.666 min and 9.842 min respectively. The peaks were well separated (resolution 4.55 and 20.2). The calibration curves were linear over the concentration range of 80% to 120% of target concentration (R² > 0.999 for ranitidine and naproxen and 0.998 for domperidone). The method is accurate with 99.5% to 100.04% recovery (% RSD < 1.23). The proposed method was successfully applied for the estimation of ranitidine hydrochloride, domperidone and naproxen and potency was found within limit. Therefore, this method can be used for the analysis of ranitidine hydrochloride, domperidone and naproxen in single or combine dosage form.