Simple, specific, accurate, precise and reproducible RP-HPLC method has been developed and validated for the simultaneous estimation of five drugs in their combined semi-solid dosage form. In RP-HPLC, analysis was carried out using Acetonitrile and 0.1M Ammonium Acetate buffer adjusted to pH 4.0 with Glacial Acetic Acid (10:90 v/v) as mobile phase and hypersil ODS-BP C18 column (250 mm x 4.6 mm, 5.0 ? particle size) as stationary phase with detection wavelength of 239 nm. Linearity was obtained in the concentration range of 30-90 ?g/ml, 11.25-33.75 ?g/ml, 3-9 ?g/ml, 15-45 ?g/ml and 0.75-2.25 ?g/ml for Ornidazole (ORN), Ofloxacin (OFL), Methyl Paraben (MP), Terbinafine hydrochloride (TRH) and Clobetasol Propionate (CLP) respectively. The average retention time for ORN, OFL, MP, TRH and CLP was 3.43 minutes, 4.51 minutes, 7.23 minutes, 8.02 minutes and 15.37 minutes respectively. The % recovery was in the range of 101.821 ââ?¬â??101.995% for ORN, 100.438 ââ?¬â??101.934% for OFL, 100.551 ââ?¬â??101.027% for MP, 100.281 ââ?¬â??100.889% for TRH and 100.659 ââ?¬â?? 101.622% for CLP. Limit of quantification for ORN, OFL, MP, TRH and CLP was found to be 4.453 Ã?µg/ml, 1.011 Ã?µg/ml, 0.248 Ã?µg/ml, 1.128 Ã?µg/ml and 0.107 Ã?µg/ml respectively. Method was statistically validated for accuracy, precision, specificity, LOQ, robustness and ruggedness according to ICH guidelines and can be used for analysis of combined dosage form.
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