Stability Indicating Method Development and Validation of Raloxifene HCl in Bulk and Formulation

Raloxifene is a medication used to prevent and treat osteoporosis in postmenopausal women and used to reduce the risk of breast cancer in those at high risk. To developed a rapid, specific, accurate and precise method for Raloxifene HCL by Stability Indicating RP-HPLC. The method was developed using the mobile phase of Water: Acetonitrile (20:80) v/v (pH adjusted to 3.5) by orthophosphoric acid. Raloxifene was separated on Inertsil C18 Column [4.6x250mm, particle size 5μm] at wavelength 284nm. The flow rate is 0.7 mL/minute and the run time of 7 minutes. The Linearity was observed in concentrations ranging from 10 to 60 ppm, and assessed by the chromatographic condition (r2 0.999). The percentage relative standard deviation in precision (intraday and interday) studies was found to be less than 2%. Stability studies is been carried out which show degradation of drug which is less than 15 %. The method was found to be accurate, precise, robust, and specific as the drug peak did not interfere with the extra peaks during the forced degradation studies.