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American Chemical Science Journal, ISSN: 2249-0205,Vol.: 3, Issue.: 4 (October-December)


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


Bahia A. Moussa1, Ramzia I. El-Bagary1 and Essam Eldin A. Osman1*

1Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt.

Article Information


(1) Sang Hak Lee, Professor, Department of Chemistry, Kyungpook National University, Daegu, 702-701, Korea.


(1) Anonymous.

(2) Anonymous.

Complete Peer review History: http://www.sciencedomain.org/review-history/1660


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 ®.

Keywords :

Raloxifene hydrochloride; differential spectrophotometry; absorbance difference; HPLC; benzophenone.

Full Article - PDF    Page 378-386

DOI : 10.9734/ACSJ/2013/4598

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