ABSTRACT

Peptic ulcer has a major threat to the world’s population over the past two decades with high morbidity and mortality. Development of many antacids has helped to treat the disease. A fixed dose of combination of Ranitidine Hydrochloride and Domperidone is given to treat the peptic ulcer. A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of Ranitidine Hydrochloride and Domperidone in synthetic mixture. Chromatographic separation was performed on a HPLC apparatus Cecil CE 4300 having pump CE4100 and reversed-phase Thermo hypersil C18 100Å column (250 mm ×4.6 mm × 5 ?m) using an isocratic elution of mobile phase consisting of Aetonitrile: Orthophosphoric acid (pH 3.5 adjusted by 3% triethylamine) (50:50 v/v) at a flow rate of 0.5 ml/min. Wavelength for HPLC method of both the drugs was selected by performing UV. Common absorbance wavelength for Ranitidine Hydrochloride and Domperidone was 296nm. The RP-HPLC method give good resolution for both the drugs. The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits. Keywords: Domperidone, Ranitidine Hydrochloride, RP-HPLC method, Validation Parameters
Publication date: 15/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_JUNE_SPCL_1049.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.6.1049