Abstract
Background: Levetiracetam is an anticonvulsant. Quantitative methods for determining levetiracetam in human plasma using high-performance liquid chromatography (HPLC) have previously been performed either without internal standards or with unsuitable internal standards. Objectives: developing method for determination of levetiracetam in human plasma by high performance liquid chromatography and validating the developed method.
Materials and methods: Human plasma samples contain levetiracetam. After developing the sample treatment procedure and chromatographic conditions, the method was validated according to US-FDA and EMA.
Results: Proteins in plasma samples containing levetiracetam and piracetam (as internal standard) were precipitated using ZnSO₄ and NaOH. The optimal chromatographic conditions: C18 column (250 mm x 4.6 mm, 5 µm), flow rate 1 ml/min, column temperature 25 oC, injection volume 100 µl, detection wavelength at 205 nm, mobile phase consisted of mixture of phosphoric acid solution of pH 2.5 and methanol in gradient program. The method met the requirements of US - FDA and EMA guidelines.
Conclusion: The method can be applied for bioequivalence studies of pharmaceutical preparations containing levetiracetam.
| Published | 2025-12-25 | |
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| Issue | Vol. 15 No. 7 (2025) | |
| Section | Original Articles | |
| DOI | 10.34071/jmp.2025.7.4 | |
| Keywords | levetiracetam, huyết tương, sắc ký lỏng hiệu năng cao levetiracetam, plasma, high performance liquid chromatography |
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