METHOD DEVELOPMENT AND PARTIAL VALIDATION OF THE MAFENIDE ACETATE DRUG IN SEMISOLID DOSAGE FORM BY RP-HPLC
A simple, specific, accurate and precise RP HPLC method has been developed for the determination of Mafenide from Semisolid dosage form by reverse phase HPLC. C18 column (Xterra RP 18, 4.6 x250mm, 5.0µm). The sample was analyzed using Potassium phosphate mono basic buffer (pH 2.5± 0.05): Methanol (87:13) as a mobile phase at a flow rate of 1.0ml/min and detection at 267nm. The retention time for Mafenide was found to be 2.852 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 50%-150% of targeted concentration ranges for drug. The method can be used for estimation of Mafenide drug in semisolid dosage form.