Analytical Method Development and Validation for the Simultaneous Estimation of Ranitidine and Dicyclomine in Bulk and Pharmaceutical Dosage Form by RP-HPLC

K. Surendra*, V. Gunasekaran, K. Venkata Arun Teja
Rao’s College of Pharmacy, Chemudugunta, Venkatachalam, Nellore, Andhra Pradesh-524320

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A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Ranitidine and Dicyclomine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Triethylamine Buffer pH 3.5 (75:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 255nm. The retention time of the Ranitidine and Dicyclomine was 2.456, 4.312 ±0.02min respectively. The method produce linear responses in the concentration range of 40-200µg/ml of Ranitidine and 1-5µg/ml of Dicyclomine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Ranitidine, Dicyclomine, RP-HPLC, Mobile phase, validation.