1.
J Pharm Biomed Anal
; 50(5): 746-52, 2009 Dec 05.
Article
in English
| MEDLINE
| ID: mdl-19595529
ABSTRACT
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.