New stability indicating RP-HPLC method for the determination of Abiraterone acetate, its related substances and degradation products in bulk and dosage form

Abstract

A robust, specific, sensitive and precise reverse-phase HPLC method has been developed for the quantitative determination of an atypical anticancer drug Abiraterone acetate and its eighteen potential impurities in drug substances. Chromatographic separation was achieved on a Kinetex C18 (4.6 mm × 150 mm, 5µ) column, using buffer (1 g of KH2PO4 in 1000 ml water and adjusting the pH 3.1 with ortho phosphoric acid) and acetonitrile in gradient elution mode. The flow rate was kept at 0.8 ml/min and thermostated at 40 °C with runtime of 65 min. The optimized method was found to produce symmetric and sharp peaks with good separation between the processes related impurities and degradation impurities. Quantification is achieved with photodiode array detection at 205 nm over the concentration range of 0.2–3.0 mg/mL. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating capability of the developed HPLC method. Developed method is validated as per ICH guidelines and found to be linear, accurate, specific, selective, precise, robust and useful during the process development as well as quality check in bulk drug manufacturing.