DEVELOPMENT AND VALIDATION OF TRAMADOL HYDROCHLORIDE IN BULK AND SOLID DOSAGE FORM BY RP-HPLC METHOD
A simple, specific, accurate and precise RP HPLC method has been developed for the determination of Tramadol Hydrochloridefrom bulk and solid dosage form by reverse phase HPLC. C18 column (Waters symmetry RP C18, 4.6 x250mm, 5.0µm). The sample was analyzed using Add 1 ml of Trifluroacetic acid in 30 Volume of Acetonitrile and 70 volume of Water used as a mobile phase at a flow rate of 1.2 ml/min and detection at 271nm. The retention time for Tramadol Hydrochloridewas found to be 7.54 min. The stability assay was performed and was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, precise, reliable, and reproducible. Calibration plots were linear over the 25%-150% of targeted concentration ranges for drug. The method can be used for estimation of Tramadol Hydrochloride drug in semisolid dosage form.