Development and Validation of a High Performance Liquid Chromatographic Method for Related Substances of Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulations

Abstract

The development and validation of reversed phase liquid chromatographic method for the determination of the related substances of Raloxifene Hydrochloride (RLH) in bulk and pharmaceutical formulation is describe. This method is simple isocratic for separation of Raloxifene Hydrochloride and related substances from each other in a thirty minutes run time. To the best of our knowledge, no method described previously in the literature has demonstrated resolution of RLH from this set of related substances. No method for the determination of related substances of Raloxifene hydrochloride is currently described in the Indian pharmacopoeia, United State pharmacopoeia or European pharmacopoeia. The proposed method was validated with respect to accuracy, precision, linearity, and specificity. In addition, the method was determined to be robust with regard to the following parameters: mobile phase apparent pH; mobile phase organic content; detection wavelength and time dependence of sample and standard stability.

Keywords: Raloxifene Hydrochloride, related substances, HPLC, pharmaceutical formulation, bulk drug