Validated stability indicating RP-HPLC method for the simultaneous determination of ofloxacin, ornidazole, clobetasol propionate, terbinafine hydrochloride, methyl paraben, propyl paraben in bulk and pharmaceutical dosage form

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Abstract :

A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for simultaneous estimation of Ofloxacin (OFL) ,Ornidazole (ORD), Terbinafine hydrochloride (TFH) , clobetasol propionate(CLP) , Methyl paraben(MP) ,propyl paraben(PP) in bulk and pharmaceutical dosage forms. The method was carried out on a Zodiac C18 (250mm x 4.6mm, 5Âµm) column with a mobile phase consisting of Ortho phosphoric acid buffer, PH 2.5 and Acetonitrile in the ratio (82:18v/v) and flow rate of 1ml/min .The detection was carried out at 255nm. The retention time for estimation of ofloxacin (0.712min), ornidazole(1.933min), Terbinafine hydrochloride (7.302min), clobetasol propionate (9.224min), Methyl paraben (4.074min), propyl paraben(7.926min) .The Linearity of proposed method was investigated in the range of 1-960 Âµg/ml with r2 value for ofloxacin (0.999), ornidazole(0.999), Terbinafine hydrochloride (0.999), clobetasol propionate (0.998), Methyl paraben (0.998), propyl paraben(0.997) .The amount of drug estimated by the proposed method was found to be in good agreement with label claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. Hence it can be applied for routine analysis of titled drug in bulk and pharmaceutical formulations.