Ulipristal acetate is used to treat uterine fibroids and for emergency birth control. The present study is a first report on development of a visible spectrophotometric method for determination of Ulipristal acetate present in bulk and tablet formulation. The method involves the sequential addition of HCl (0.1 N) and Napthol Blue Black solution to Ulipristal acetate. Cation formed on tertiary amine group of Ulipristal acetate attracts anion of naphthol blue black (an acid dye) to develop a coloured ion-association complex. From the aqueous phase, the chromophore is extractable into chloroform, which exhibits λmax at 640 nm. As per the existing guidelines of ICH, various parameters of the method were tested for validation. Regression analysis (r > 0.999) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (2.50 – 15.00 μg mL-1). The % recovery values falls in 99.80 – 100.72 range. %RSD results of both precision studies were observed in the range 0.007 – 0.560, indicating the satisfactory precision of the method. Low values of R.S.D. (< 1 %) were observed indicating that the proposed method is reproducible, accurate and precise. The proposed method can be used in quality control laboratories for routine analysis of Ulipristal acetate (bulk drug and pharmaceutical dosage forms) without requirement of expensive instruments.
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[v1] 2019-05-19 02:05:22
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