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Original Articles Open Access
The aim of this study was to develop and validate a dissolution test for Raloxifene hydrochloride (RLX) in pharmaceutical dosage forms using a reverse phase high performance liquid chromatographic (RP-HPLC) method. Efficient chromatographic separation was achieved using a ZodiacSil C4 column (150x 4.6 mm, 5μ), with simple mobile phase combination delivered in an isocratic mode and quantitation was by ultraviolet detection at a wavelength of 287 nm. The mobile phase consisted of buffer and acetonitrile (64:36% v/v) delivered at a flow rate of 0.7 ml min-1. Buffer consisted of 50 mM potassium di-hydrogen ortho phosphate monohydrate, pH adjusted to 3.0 using ortho-phosphoric acid. The calibration curve was linear (R2 > 0.999) over the concentration range of 2.5 – 15 μg mL-1 of the analyte. The optimized dissolution conditions include the USP apparatus II at a paddle rotation rate of 50 rpm and 900 mL of 0.001 N HCl (pH 3.0) as dissolution medium at 37 ± 0.5°C. The present method was validated with respect to linearity, specificity, precision, accuracy and robustness. The system suitability parameters, such as theoretical plates, tailing factor and relative standard deviation (RSD) between five standard replicates were well within the limits. The stable nature of drug in the prescribed dissolution medium could be inferred from the stability studies. The developed dissolution test was adequate for its purpose and can be applied for the quality control of RLX in pharmaceutical dosage forms.
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Author(s): Sandeep Kalepu Vijaykumar Nekkanti Mohanvarma Manthina and Veerabhadraswamy Padavala
Raloxifene hydrochloride, dissolution, RP-HPLC, validation, chromatographic separation