The present work describes a validated RP-HPLC method for simultaneous estimation of Ranitidine HCL (RANI) and Drotaverine (DROTA) in combined dosage form. The method was performed on a Gradient HPLC instrument using Water: Methanol: Acetonitrile (10:80:10 v/v/v), pH adjusted at 8.5 with Diethyl amine as a mobile phase. Areas were recorded at 324 nm for both the drugs and retention time was found at 2.76 min and 4.58 min for Ranitidine and Drotaverine respectively at 1.0 ml/min flow rate. The selected chromatographic conditions were found to quantitatively determine Ranitidine and Drotaverine in a combined dosage form without any physical separation. Linearity was found over the range of 5-50 μg/ml for Ranitidine and 2-12 μg/ml for Drotaverine. The values of Limit of Detection were found to be 0.077 μg/ml for Ranitidine and 0.215 μg/ml Drotaverine. The values of Limit of Quantition were found to be 0.232 μg/ml for Ranitidine and 0.652 μg/ml for Diclofenac. The proposed method was found to be fast, accurate, precise, reproducible and rugged and can be used for simultaneous analysis of these drugs in tablet.
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