CZE separation of nitrogenous drugs in cationic form

Abstract

A rapid and efficient capillary zone electrophoresis method was developed for Quality Control analysis of pharmaceutical preparations containing antihistamines, decongestants and anticholinergic remedies: chlorpheniramine, diphenhydramine, ephedrine, isopropamide, pheniramine. These analytes were separated in cationic form optimizing the experimental conditions in 60 mM tetraborate buffer pH = 9.2 as a BGE (Background Electrolyte) on a Beckman P/ACE System MDQ instrument. The effective capillary length was 48 cm, I.D. = 75 μm, the applied voltage 15 kV, and the temperature 25 °C. Detection was performed by a DAD (Diode Array Detector) at 210 nm. Separation time was less than 8 min. After experimental conditions optimization, the proposed method was validated. Precision of migration time (t_m) ranging from 0.19% to 0.29% and corrected peak area (A_c) from 2.54% to 3.68%. The linearity of detector response was tested in the range 5–40 μg ml⁻¹ obtaining the 0.9962 ≤ r² ≤ 0.9982. LOD and LOQ, accuracy (recovery) and ruggedness were evaluated for each analyte demonstrating the good reliability of the method. Analysis of the pharmaceutical real sample was performed.