Abstract

Background: Amlodipine, a calcium channel blocker, is commonly prescribed to treat high blood pressure. In Vietnam, there is no method of quantifying amlodipine in plasma by capillary electrophoresis. Therefore, the thesis was carried out with the objective: Developing and validating a method for quantifying amlodipine in human plasma by capillary electrophoresis. Materials and methods: Human plasma samples contain amlodipine. After optimizing the process, the method was validated according to the guidelines for validation of bioanalytical methods of US-FDA and EMA. Results: Amlodipine and nifedipine as internal standard (IS) were alkalized with sodium hydroxide and extracted from human plasma by liquid - liquid extraction technique with ethyl acetate. Electrophoresis conditions: Fused-silica capillary column (effective column length: 48.5 cm, total column length 57.5 cm, outside diameter: 75 µm, internal diameter: 75 µm), background electrolyte: 50 mM borate buffer at pH 8.6 containing 20 mM sodium dodecyl sulfate, voltage: +25 kV, current: 300 μA, column temperature: 25 ± 1 oC, sample injection: 35 mBar - 7s, detection at 237 nm. The method was validated and met US-FDA and EMA requirements. Conclusion: The method can serve as a basis in bioequivalence studies of medicinal products containing amlodipine.