Spectrophotometric and Chromatographic Methods for the Estimation of Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulations

Aim: To develop simple, accurate and precise spectrophotometric and chromatographic methods for the estimation of Raloxifene Hydrochloride (RXF) in pure and pharmaceutical dosage forms.

Study Design: Spectrophotometric and chromatographic methods.

Place of Study: Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.

Methodology: The differential spectrophotometric method was based on the measurement of the absorbance difference (∆A) at 333.4 nm of alkaline raloxifene hydrochloride solutions in 0.1 N NaOH against its acidic solutions in 0.1N HCl. RP-HPLC was developed using benzophenone as an internal standard, where the mobile phase used was acetonitrile: water (50:50, v/v), delivered at a flow rate of 1.2 ml/min on a stationary phase composed of C18 column; and the detection was carried out at the λmax of RXF (289 nm).

Results: The recovery percentage for RXF was found to be 100.46 ±0.65 and 99.96 ±0.83 for the two methods, respectively. The methods were validated as per ICH guidelines regarding accuracy, precision and system suitability.

Conclusion: All the results obtained were found to be within the acceptable limits. The methods were successful to estimate RXF in bulk powder and pharmaceutical preparation Evista ®.