NOVEL RP-HPLC METHOD FOR THE QUANTIFICATION OF ABIRATERONE ACETATE
Abstract
Simple, rapid, accurate and specific RP-HPLC method has been developed for quantitative estimation of
Abiraterone acetate in bulk and tablet. Separation was attained by using Acclaim C18 column (50mm x
4.6 mm, 5ï) at 25ï‚°C and 80:20 v/v acetonitrile:ammonium acetate buffer(10mM) of pH 6.0 with flow rate
of 1ml/min as mobile phase and the drug was detected at 254 nm. Analytical method was said to be
linear over a range of 0.125-60 ïg/ml with correlation constant of 0.999. Method was appeared to be
precise, robust and rugged. LOD and LOQ were found to be 10 ng/ml and 50 ng/ml respectively and the
mean recovery value as 100.52%.Stability indicating capability of this method has been demonstrated by
analyzing stressed samples of drug and found labile to acidic, alkaline, oxidative, thermal and photolytic
conditions. Above method was applied for the estimation in API, formulation and dissolution testing of
the dosage form. Percentage assay of the formulation was found to be 101.66%w/w. Drug released to an
extent of 85.29% at 30 minutes as per FDA published method. Thus, the analytical procedure is reliable
and offers advantage in terms of speed; so could be effectively used for the routine quality control
purpose.
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