title: Development and validation of stability-indicating HPLC and UPLC methods for the determination of bicalutamide.
abstract: Six new process related impurities (Imp-08, Imp-09, Imp-10, Imp-12, Imp-13 and Imp-14) of bicalutamide (BCT) have been reported in this paper. BCT was subjected to oxidative, acid, alkaline, hydrolytic, thermal and photolytic degradation conditions and found to degrade in alkaline condition, yielding Imp-11. Stability-indicating high-performance liquid chromatography and ultra-performance liquid chromatography methods were developed for the determination of BCT in the presence of its 14 process-related impurities and 1 degradant by using Zorbax SB phenyl column (150 × 4.6 mm × 3.5 µm) and HSS T3 column (100 × 2.1 mm × 1.8 µm), respectively. Both the methods were validated as per International Conference on Harmonization guidelines. Quantitation limits (QL) were found be in the ranges of 0.02-0.03% for both the methods. Precision was evaluated by replicate analysis in which % relative standard deviation (RSD) values for areas were found below 2.0. Linearity for the impurities was established in the range of QL to 200% of the specification level and the correlation coefficients derived from of the respective calibration curves were approximately 0.999. The recoveries obtained for purity (90-100%) and assay (98-102%) ensured the accuracy of the developed methods.
authors.affiliation: Hetero Drugs Ltd. (R&D), Plot No. B. 80 & 81, APIE, Balanagar, Hyderabad 500018, India. raman@heterodrugs.com
authors.forename: V V S S Raman
authors.initials: VV
authors.lastname: Nanduri
authors.forename: V S S Prasad
authors.initials: VS
authors.lastname: Adapa
authors.forename: Ratnakar Reddy
authors.initials: RR
authors.lastname: Kura
mesh_terms: D000813:Anilides / Q000032:analysis* / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D016018:Least-Squares Analysis; D009570:Nitriles / Q000032:analysis* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014105:Tosyl Compounds / Q000032:analysis* / Q000592:standards
chemical_list: D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide