Development and validation of a stability indicating LC method for the assay and related substances determination of exemestane, an aromatase inhibitor.
A selective stability indicating HPLC method was developed and validated for quantification of impurities (process related and degradants) and assay determination of Exemestane. Stability indicating power of the method was established by forced degradation experiments and mass balance study. The chromatographic separation was achieved with Hypersil BDS-C-18 using gradient elution. The developed method is validated for parameters like accuracy, linearity, LOD, LOQ, ruggedness. Box-Behnken experimental design was applied to check the robustness of the method.
Suresh Kumar
R
R
Integrated Product Development Organization, Dr. Reddy's Laboratories, Bachupally, Hyderabad 500072, India. sureshk@drreddys.com
Narasimha Naidu
M
M
Srinivasulu
Kasa
K
Raja Sekhar
K
K
Veerender
M
M
Srinivasu
M K
MK
D000730:Androstadienes / Q000032:analysis*; D001141:Aromatase / Q000737:chemistry; D047072:Aromatase Inhibitors / Q000032:analysis* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000295:instrumentation* / Q000379:methods*; D004355:Drug Stability; D008956:Models, Chemical; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods; D013696:Temperature
D000730:Androstadienes; D047072:Aromatase Inhibitors; D001141:Aromatase; C056516:exemestane