DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF BECLOMETHASONE DIPROPIONATE AND KETOCONAZOLE IN COMBINED DOSAGE FORM

Abstract

A simple, selective and rapid reversed phase high performance liquid chromatographic (RPHPLC) method for the analysis of beclomethasone dipropionate and ketoconazole in combined dosage form has been developed and validated. The chromatographic system consisted of a quaternary pump with auto-sampler and PDA detector on a reversed-phase C18 column (250 mm × 4.6 mm i.d, 5 ?m particle size) at ambient temperature with a mobile phase consisting of acetonitrile : acidic water(pH is adjusted 6.0 with acetic acid) ( 57 : 43, v/v) at flow rate of 0.8 ml/min and detection wavelength of 254 nm  and the retention time was about 2.81 minutes for ketoconazole(KTZ) and 7.69 minutes for beclomethasone dipropionate(BCD). The method is selective and able to resolve drug peaks. The peaks of beclomethasone dipropionate and ketoconazole were well separated. The linearity of the calibration curves for each analyte in the desired concentration range was good (R²>0.99). The method was accurate with recoveries in the range of 98-102% for both drugs and precise (%RSD of intra day variation were 0.60 – 0.78 for beclomethasone dipropionate and 0.74 - 1.05 for ketoconazole and %RSD of inter day variation were 0.89 - 1.72 for beclomethasone dipropionate and 0.76 – 1.69 for ketoconazole). The proposed method was found to be highly sensitive, accurate and precise and thatswhy this method can be used as a more convenient and efficient option for the analysis of beclomethasone dipropionate and ketoconazole in combined dosage form.