Journal of Applied Pharmacy
Open Access
ISSN: 1920-4159
ISSN: 1920-4159
Adams D
Canada
Research Article
A Four-Dimensional (4D) Stability Indicating Analytical Method Optimization and Potency Assay Prediction Using MS and UV Peak Tracking
Author(s): Blasko A, Tam J, Ahmad IAH, Gunasekera S, Oshchepkova I, Galin A, Vazhentsev A, Tashlitsky V and Adams DBlasko A, Tam J, Ahmad IAH, Gunasekera S, Oshchepkova I, Galin A, Vazhentsev A, Tashlitsky V and Adams D
A total of 60 peaks generated by forced degradation of three active pharmaceutical ingredients (APIs) were used for the column selection in the development of a stability indicating HPLC-UV analytical method using LC-UV and LC-MS peak tracking. Two mobile phase additives and two organic modifiers were evaluated while screening a list of carefully chosen chromatography columns. The column screening was utilized and the best column selected based on total number of resolved peaks, resolutions, peak widths, and peak shapes. 0.1% TFA in ACN/water was used for the initial screening and optimization of the gradient profile. Three different concentrations of TFA in ACN/water were also evaluated. The optimum TFA concentration, 0.10% (8.77 mM), was considered as optimum for further gradient optimization based on the resolution of critical pairs. After the selection of column, mobile phase and .. View More»