Systematic Development and Validation of a RP-HPLC Method for Estimation of Abiraterone Acetate and its Degradation Products

Abstract

The present study described the development of a reversed-phase liquid chromatographic method for the estimation of abiraterone acetate by Quality by Design (QbD) approach. Using an isocratic solvent system for the mobile phase, the chromatographic estimation of analyte was performed on a Hypersil BDS C18 column using mobile phase mixture containing acetonitrile and water with pH adjusted with 0.1% v/v orthophosphoric acid (15:85%v/v ratio), flow rate 1.0 mL.min−1 and detection at 250 nm using photodiode array detector. Systematic development of the chromatographic method was carried out by factor screening using a half-factorial design which suggested organic modifier (%), flow rate (mL.min−1) and autosampler temperature (°C) as influential variables. Further, the method was optimized by Box–Behnken design and trials performed were evaluated for the area under peak, retention time, theoretical plate count and tailing factor as the responses. Validation of the developed method showed good linearity, accuracy, precision and sensitivity. Evaluation of the stability-indicating profile of the method using forced degradation studies revealed the formation of a possible degradation product under acidic and alkaline conditions, while no such degradation product peaks were observed under the oxidative environment. Overall, the study construed the successful development of HPLC assay method for pharmaceutical applications.

Systematic Development of Solid Lipid Nanoparticles of Abiraterone Acetate with Improved Oral Bioavailability and Anticancer Activity for Prostate Carcinoma Treatment

“…The analytical estimation of the drug abiraterone acetate was carried out as per our previously developed and validated high-performance liquid chromatography (HPLC) method. 35 Waters Alliance e2695 HPLC system (Water Co, MA, U.S.A.) equipped with a separating module, autosampler, degasser, column oven, and photodiode array detector (Water 2996) was used for the analysis. The estimation was performed on a Hypersil BDS C 18 column (250 × 4 mm; 5 μm; Thermo-Fisher, Tokyo, Japan) using 0.1% orthophosphoric acid in water (pH 3.5) and acetonitrile in the ratio of 15:85 as mobile phase and the flow rate was kept at 1 mL·min –1 .…”

“…The amount of free drug (unentrapped) in nanoparticles was quantified by HPLC. 35 Entrapment efficiency was calculated using the following eq 1 …”

“…The analytical estimation of the drug abiraterone acetate was carried out as per our previously developed and validated high-performance liquid chromatography (HPLC) method . Waters Alliance e2695 HPLC system (Water Co, MA, U.S.A.) equipped with a separating module, autosampler, degasser, column oven, and photodiode array detector (Water 2996) was used for the analysis.…”

“…The amount of free drug (unentrapped) in nanoparticles was quantified by HPLC. 35 Entrapment efficiency was calculated using the following eq 1 Entrapment efficiency (%) Amount of drug taken Amount of unentrapped drug Amount of drug taken 100…”

Study on Stress Degradation Behaviour of Abiraterone Acetate in Film Coated Tablets and Identification of Major Stress Degradation Product by LC-UV-ESI-MS

“…Silica (BDS) C 18 (250 mm×4 mm, 5 μm)Stability indicatingBeg et al[9] HPLCPotassium phosphate buffer:ACN (40:60) 1 Hypersil ODS C 18 (150 mm×4.6 mm, 5 μm) Stability indicating Kavitapu et…”