Development and Validation of RP-HPLC Method for the Estimation of Raloxifene in Marketed Formulations

Abstract

A Simple, selective, accurate, economical reverse phase high performance liquid chromatography (RP-HPLC) was developed for estimation of Raloxifene in pharmaceutical formulations. Chromatographic separation achieved on a C 18 column (Use INERTSIL, C 18 , 5μ, 250×4.6 mm i.d.) with mobile phase containing acetonirile and ammonium acetate buffer in the ratio 75:25 v/v. The flow rate was 1.0 mL/min and effluent was monitored at 254 nm. The retention time was 4.413 min. The method was validated in terms of linearity, accuracy and precision. The linearity curve was found to be linear over 2.5 -12.5 μg/mL. The limit of detection and limit of quantification were found to be 0.0202 and 0.202 μg/ml respectively. The proposed method was successfully used to determine the drug content of marketed formulations.