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METHOD DEVELOPMENT AND VALIDATION OF A VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE ASSAY OF MIFEPRISTONE IN PHARMACEUTICIAL FORMULATIONS USING GOLD (III)

Abstract

K. Nagabhushana Reddy, A. Giri, B. Saritha, Vijayabhaskara Reddy, T. Sreenivasulu Reddy

Gold (III) reacts with mifepristone in the pH range 1.5-3.5 forming a yellow coloured complex. This colour reaction is exploited for the development of a visible spectrophotometric procedure for the determination of mifepristone. The absorption spectrum o f the complex shows a maximum at 430 nm. pH 2.5 is selected for analytical studies. A ten fold excess of Au (III) is sufficient to produce maximum absorbance. The composition of the complex is 1.1 [Au (III): MPT]. The absorbance of the complex varied linearly with the amount of mifepristone. The straight line relation between absorbance and amount of mifepristone is A = 0.0242C+ 0.0003. The linear plot shows that Beer’s law is obeyed in the range 2.0-45.0 µg/ml of mifepristone. The molar absorptivity and sandell’s sensitivity are 1.040 × 104 l mol-1 cm-1 and 0.0413 µg cm-2 respectively. The standard deviation of the method for ten determinations of 15 µg/ml mifepristone is 0.0014. The correlation coefficient () of the experimental data of the calibration plot is 0.9997. The proposed spectrophotometric method was validated according to ICH specifications. The validation parameters such as, linearity, accuracy, precision, LOD, LOQ and ruggedness were studied. The proposed method for the quantitative assay of mifepristone was successfully applied for its assay in pharmaceutical formulations. The method is accurate, precise, highly sensitive and selective, for the assay of mifepristone

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