Comparison Between Cyano and C-18 Columns for Separation of Trandolapril and Verapamil with ESI-Q-ToF-MS Characterization of Acidic and Basic Degradation Products: Stability Indicating Assay Methods

Autor: Ragaa Magdy, A. Hemdan, Maha Farouk
Rok vydání: 2018
Předmět:
Zdroj: Chromatographia. 81:1163-1172
ISSN: 1612-1112
0009-5893
DOI: 10.1007/s10337-018-3547-8
Popis: Different stationary phases were compared for their separation efficiency of Trandolapril (TRP) and Verapamil (VRP) in presence of acidic, basic, oxidative, and photolytic degradation products. The separation was applied on two different stationary phases. The first stationary phase was the conventional C18, whereas the second was the more polar cyano stationary phase. However, for the conventional C18 packing, two columns with two different lengths were used, 250 and 150 mm. Optimum performance for C18 columns was obtained using acetonitrile: potassium di-hydrogen ortho-phosphate buffer pH 6 adjusted by 0.1 M NaOH (50:50 v/v) as a mobile phase while for cyano column it was acetonitrile: potassium di-hydrogen ortho-phosphate buffer pH 4.5 (25:75 v/v). For both stationary phases, the flow rate was 1 mL min−1 and the detection wavelength was 215 nm. The validations of all the adopted methods were done as per ICH guidelines. The comparison was accomplished in terms of resolution, tailing factor, column efficiency, and total run time of analysis. Both C-18 columns showed superior results over cyano column. The C-18 column (150 mm) exhibited better results than C-18 (250 mm) column in terms of column efficiency and total run time. The results were compared with the reference method and no significant differences were found. In addition, one-way ANOVA testing was done to compare the three methods.
Databáze: OpenAIRE