• A.Shirisha
• Dr. M. Ajitha
• K.S.L.Harika

A specific, precise, and accurate RP-HPLC method has been developed and validated for the quantitative analysis of Abiraterone in tablet formulation. An Isocratic separation was achieved using Symmetry Waters C18 150 x 4.6 mm, 5mm. column with a flow rate of 0.8ml/min. The injection volume was 10μL and detection wavelength was at 235nm.The column and sample temperature was maintained at 30°C. Run time was 5 minutes. The retention time of Abiraterone peak was about 2.35 minutes. Isocratic elution was performed with mobile phase composition 0.01N Na2HPO4.H2O(5 pH)Buffer : Acetonitrile, in the ratio of 70:30% v/v. The Mobile phase was used as Diluent. The method was validated for specificity, linearity, precision, accuracy and robustness. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug product (forced degradation). The method was linear over the concentration range from 25% of target concentration to 150% of target concentration (r2 = 1.000). The method was found to be Robust and suitable for the quantitative analysis of Abiraterone in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Abiraterone peak in chromatogram, demonstrating the stability-indicating method.

Abiraterone, Stability-indicating, RP-HPLC.

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF ABIRATERONE BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 1, page no.489-505, January-2019, Available :http://www.jetir.org/papers/JETIR1901366.pdf

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF ABIRATERONE BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 1, page no. pp489-505, January-2019, Available at : http://www.jetir.org/papers/JETIR1901366.pdf