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Five simple, sensitive, accurate and precise methods were developed for determination of raloxifene (RLX) in pure form as well as in its pharmaceutical preparation. Method [A] is HPLC stability–indicating method, where the intact drug (RLX), the internal standard (methocarbamol) and RLX degradation products were separated using a YMC-pack ODS-AQ C18 column (150 mm X 4.6 mm ID, 3μm particle size ) using acetonitrile–0.05 M KH2PO4 adjusted to pH 2.5 using H3PO4 (50 : 50 v/v ) as a mobile phase at a flow rate 1 ml/min. and UV detection at 280 nm, where a good linearity was obtained in the range of 0.5 – 8 μgml 1 .The LOD was 0.077 μg ml -1 and the LOQ was 0.258 μgml -1 . Method [B] depended on measurement of the difference absorbance (ΔA) of the drug in the presence of its degradate between solutions in methanolic 0.1 M HCl and 0.1 M NaOH at 285 nm. Beer’s low was obeyed in the range of 3 – 27 μgml -1 . LOD and LOQ were found to be 0.233 and 0.778 μg ml 1 , respectively. Method [C] is stability – indicating First-Derivative ( 1 D) for the determination of intact RLX in presence of its degradation product at 268 nm in the range of 3 – 18 μg ml -1 with LOD of 0.254 μg ml and LOQ of 0.849 μg ml -1 . Method [D] depended on ion pairing of RLX with eosin-Y dye at pH 3.5 to produce red coloured complex measured at 545 nm. Beer’s low was obeyed in the range of 2 – 20 μgml -1 . LOD and LOQ were found to be 0.276 and 0.920 μg ml -1 , respectively. Method [E] depended on ion pairing of RLX with bromothymol blue (BTB) dye at pH 2.6 to form a chloroform-soluble coloured ion association complex. The formed complex could be extracted and measured at 420 nm. Good agreement with Beer’s low was found in the range of 4 – 28 μgml -1 . LOD and LOQ were found to be 0.633 and 2.110 μg ml -1 , respectively. The percent recoveries ± RSD% of these methods were 100.83±0.920, 100.24±0.724, 100.15±0.586, 100.26±0.383 and 99.98±0.261, respectively. The obtained results were compared with those of the reported method and no significant difference was observed regarding accuracy and precision. INTRODUCTION: Raloxifene hydrochloride (RLX), 6-Hydroxy-2-(p-hydroxyphenyl) benzo[b]thien-3-ylp-(2-piperidinoethoxy) phenyl ketone hydrochloride, is a second generation selective estrogen receptor modulator. It is a non-steroidal that belongs to the benzothiophene class of compounds. It is used in the treatment and prevention of osteoporosis and invasive breast cancer in postmenopausal women ( Martindale 35: The Complete Drug Reference CD and The Merck index 2006 ).

HPLC AND SPECTROPHOTOMETRIC STABILITY – INDICATING STUDY OF RALOXIFENE IN PURE FORM AND TABLETS