Abstract
The aim of present work was to develop and validate a simple, fast and reliable isocratic HPLC method for determination of raloxifene hydrochloride in pharmaceutical dosage form. Chromatographic Separation was achieved by using Agilent technologies model G4288A. Gradient HPLC-1120 , Compact low pressure binary Gradient Pump Consisting Of vacuum in built degasser unit non-PDA UV-vis detector equipped with a manual injection system with 50 uL loop and the eluted analytes for drug was traced by UV detection at 287nm. The method was found to be linear over a wide concentration range (0.1-20 µg/mL) with a correlation coefficient (r) of 0.9995. The LOD and LOQ were 21 and 63 ng/mL for RLX. These results indicate that method is sensitive enough for therapeutic assay. The % RSD values for three selected concentrations were found to be 0.14, 0.51 and 0.75% revealed the high system accuracy. The relative standard deviations (RSD) obtained at three concentrations (n = 6) in the range of 8-10 µg/mL was 0.016-0.018 % for the intraday assay and 0.016-0.024% for interday assay revealed good precision. The specificity was demonstrated that drugs were free of interference from potential impurities. % RSD, theoretical plates and Rmin were not significantly affected when the experimental parameters (such as flow rate, gradient program) were altered and thus concluded that the method was robust.
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