QUANTITATIVE DETERMINATION OF RALOXIFENE HYDROCHLORIDE IN BULK AND TABLET FORMULATION BY UV-SPECTROPHOTOMETRY AND FIRST ORDER DERIVATIVE USING AREA UNDER CURVE METHOD

摘要

Raloxifene hydrochloride (RLF) is a non-steroidal, selective estrogen receptor modulator used in the treatment and prevention of osteoporosis in postmenopausal women. Two simple, rapid and economical 'zero order UV-spectrophotometric (method I)' and 'first order derivative spectrophotometric (method II)' using area under curve (AUC) technique have been developed for estimation of RLF in bulk and tablets. In 0.1 N NaOH, RLF showed maximum absorbance at 303.5 nm. In method I, AUC between two wavelengths 275.0 nm & 350.0 nm were selected. In method II, UV-spectrum of RLF was derivatized into first order and two wavelengths 303.0 nm and 385.0 nm were selected for determination of AUC. In both these methods, RLF obeyed linearity in the concentration range of 2-10 mcg/mL (r~2>0.99). Proposed methods were applied for tablet formulations and amounts of RLF estimated by method I and method II were found to be 100.08±0.68 and 99.78+0.94, respectively. Both these methods were validated statistically and by recovery experiments.