Innovative Method Development and Validation of Stability Indicating RP-HPLC Method for Determination of Ormeloxifene Hydrochloride in Bulk and Pharmaceutical Dosage Form

The present method describes the development of a validated RP-HPLC for determination of ormeloxifene hydrochloride in presence of its degradation products or other pharmaceutical excipients. The drug substance was subjected to stress conditions of acid (2N HCl), alkali (2N NaOH), oxidative (30%H₂O₂), neutral, thermal and photolytic studies. Seperation was carried out on Agilent XDB C18 column,(250×4.6mm I.D, Particle size 5μm) by using mobile phase consisting of a mixture of buffer: acetonitrile: methanol (20:35:45,v/v/v) with the flow rate of 1.0mL/min. UV detection was performed at 245nm and retention time was found to be 5.48min. The method was validated for linearity, accuracy and precision. Linearity for ormeloxifene was in the range of 30-90μg/mL with correlation coefficient values 0.9999. The mean recoveries were found in the range of 99.73-100.84% and the %RSD was found to be less than 2% indicated, that the method is more accurate and precise. The Limit of Detection and Limit of Quantification were 0.11μg/ml and 0.32ì g/ml respectively, which indicate sensitivity of the method. No interfering peaks were found in the chromatogram indicating that excipients used in tablet formulations did not interfere with the estimation of the drug by proposed HPLC method.