title: Development and validation of stability indicating method for the determination of exemestane by reverse phase high performance liquid chromatography.
abstract: Exemestane is an aromatase inhibitor used in the treatment of breast cancer. A selective stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed which can separate and accurately quantitate low levels of exemestane. The stability-indicating capability of the method was demonstrated by adequate separation of exemestane and all the degradation product peaks from exemestane peak and also from each other in stability samples of exemestane. Chromatographic separation of exemestane and its degraded products were achieved by using isocratic elution at a flow rate of 1.0 mL/min on a C18 reverse phase column (Phenomenex, size: 250 × 4.60 mm, particle size 5 μm) at ambient temperature. The mobile phase used for the analysis was acetonitrile-water (60:40, %v/v) with UV visible detection at 242 nm. The proposed method was used to study the degradation behavior of drug under various stress conditions as per ICH recommended guidelines.
authors.affiliation: SVKM's NMIMS School of Pharmacy and Technology Management, Near Bank of Tapi River Agra-Mumbai Road Babulde Shirpur 425405, Dhule Maharashtra, India. bharathkph@gmail.com
authors.forename: Bharath
authors.initials: B
authors.lastname: Konda
authors.forename: Ravi N
authors.initials: RN
authors.lastname: Tiwari
authors.forename: Harshal
authors.initials: H
authors.lastname: Fegade
mesh_terms: D000730:Androstadienes / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004355:Drug Stability; D016018:Least-Squares Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013696:Temperature
chemical_list: D000730:Androstadienes; C056516:exemestane