XÂY DỰNG QUY TRÌNH ĐỊNH LƯỢNG ĐỒNG THỜI METFORMIN, GLICLAZID VÀ ATORVASTATIN TRONG HUYẾT TƯƠNG NGƯỜI BẰNG PHƯƠNG PHÁP HPLC-PDA

Summary
Hypoglycemic agents including metformin (MET) and gliclazide (GLZ) are often used in combination with the lipid-lowering drug atorvastatin (ATOR) for type 2 diabetic patients with hyperlipidemia. The purpose of this study was to establish a high-performance liquid chromatography (HPLC) method to simultaneously determine concentrations of MET, GLZ and ATOR in human plasma in order to contribute to optimize the treatment efficacy of MET, GLZ and ATOR or apply to bioequivalence studies. MET, GLZ and ATOR were extracted from plasma samples with methanol. 10 µL of sample extract was injected onto Phenomenex C8 column (150 mm x 4.6 mm, 5.0 µm) at 40 °C on Waters 2695 XE systems connected with PDA (photodiodes array) detector at 228 nm. The mobile phase consisted of phosphate buffers (pH 3) and methanol with a flow rate of 1 mL/min. The results showed that total chromatographic runtime was 17.5 min. Retention times of MET, GLZ và ATOR were 4.09; 8.59 and 9.55 min, respectivily. The concentrations of MET, GLZ and ATOR were in the linear range from 0.25 – 20 µg/mL. Mean intra-day and inter-day precision and accuracy at low, medium and high concentrations (QC) for MET, GLZ and ATOR were all > 85%. LLOQ and limit of detection (LOD) were 0.25 µg/mL and 0.08 µg/mL, respectively. Recoveries ranged from 73.11 % – 78.65 % for all MET, GLZ and ATOR. No interference was found in the assay. In conclusion, a simple and reliable HPLC method was developed to simultaneously quantify the MET, GLZ and ATOR concentrations in plasma.
Keywords: Metformin, gliclazide, atorvastatin, plasma, HPLC.

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