Optimized and Validated Spectrophotometric Methods for the Determination of Roxatidine Acetate Hydrochloride in Drug Formulations Using 2,3-Dichioro-5,6-dicyano-1,4-benzoquinone and p-Chloranilic Acid

摘要

Two simple and sensitive spectrophotometric procedures were proposed for the determination of roxatidine in pure form and in tablets. Both the methods are based on the charge transfer complexation reaction of the drug with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) or p-chloranilic acid resulting in coloured products. In each case, the absorbance measurement was made at 530 nm. Beer's law was obeyed in the concentration ranges 5-65 and 10-260 mu g ml~(-1) with DDQ and p-chloranilie acid, respectively. A series of variables were studied to optimize the reaction conditions. No interferences were observed from the common excipients present in the formulations. The described methods were applied successfully for the analysis of roxatidine in pharmaceutical preparations. Statistical comparison of the results with those from the developed UV reference method reveals and excellent agreement. Both the methods are validated statistically. Accuracy and precision are not significantly different.