Capillary Electrophoresis Method for Simultaneous Quantification of Hypocholesterolemic Drugs in Binary Mixture Formulation: Fast, Green, and Cost-Effective Alternative to HPLC

Author(s)

de Souza, Antonio Marcos Callejo ; Fajardo, Frank Alonso Gavilano ; Rashid, Anas ; Tavares, Marina Franco Maggi ; Prado, Maria Segunda Aurora

• Document type: Journal article
• Source: Chromatographia; v. 86, n. 4, p. 15-pg., 2023-03-15.

Abstract

A fast and sustainable environment-friendly micellar electrokinetic chromatography coupled with a diode array detector was investigated and validated in accordance with ICH requirements for the simultaneous quantification of ezetimibe and simvastatin in a tablet binary mixture formulation. Drugs' separation from their internal standard and degradation products was achieved using the optimized electrophoretic conditions: 50 mu m i.d. x 30 cm fused-silica capillary, background electrolyte composed of 20 mmol L-1 sodium tetraborate buffer solution (pH 9, adjusted with o-phosphoric acid), 30 mmol L-1 sodium dodecyl sulfate, 12% acetonitrile; with detection at 238 nm and voltage of + 30 kV. Drugs were separated in less than 6 min. The method was linear with determination coefficients 0.9956 and 0.9920 for ezetimibe and simvastatin, respectively; and precise (intra-day 1.05% and 0.38%; inter-day 1.20% and 0.69%) for ezetimibe and simvastatin, respectively. Accuracy was tested through recovery and mean values (101.0 +/- 0.77% for ezetimibe and 100.4 +/- 0.35% for simvastatin) were obtained. The proposed method is the first that determined ezetimibe and simvastatin in presence of their degradation products. This method can be successfully used in quality control laboratories as an alternative to HPLC technique for the simultaneous quantification of ezetimibe and simvastatin in their combined drug products and could also be used as a stability-indicating method. The proposed method greenness profile was confirmed using Green Analytical Procedure Index and Analytical GREEnness tools with a final score of 11 and 0.81, respectively. (AU)

• FAPESP's process: 12/50595-8 - Application of electrophoretic and cromatographic methods for simultaneous determination of drugs used in the treatment of hypercholesterolemia
• Grantee: María Segunda Aurora Prado
• Support Opportunities: Regular Research Grants