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- W2915459040 abstract "Levetiracetam (LEV) has been used for the treatment of epilepsy, especially partial seizures, owing to its pharmacokinetic profile, but the LEV impurity C (IMPC), pyridine-2-ol, is regarded as a main toxic substance. The existing methods for the analysis of LEV and its impurity are not fully effective. This study aimed to develop a simple gas chromatography-mass spectrometric (GC–MS) technique, for the first time, to analyze LEV and its toxic IMP-C without derivatization process, and to compare the technique with the previously reported UPLC method. Two different dosage forms of LEV, i.e. the tablet and syrup, plus IMP-C were determined by the same procedure. The analysis, without any derivatization processes, was performed using the gas chromatography coupled with Single Quadrupole Mass Spectrometer in the selected ion monitoring (SIM) mode that used electron ionization with 70 eV energy from 4 to 400 Amu. The helium carrier gas was run through a TG-5MS column with the flow rate of 1 mL/min via temperature programming. USP validation parameters were employed for the method validation regarding linearity and accuracy. The proposed method was successfully utilized to determine LEV in the tablet and syrup dosage forms. The statistical analysis showed no significant difference (p > 0.05) between this novel technique and the available UPLC method. Overall, the newly developed chromatographic method is characterized as simple and very sensitive for the simultaneous analysis of LEV and its impurity." @default.
- W2915459040 created "2019-03-02" @default.
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- W2915459040 date "2019-05-01" @default.
- W2915459040 modified "2023-10-03" @default.
- W2915459040 title "Simple GC–MS method for analysis of Levetiracetam and process-related toxic impurity" @default.
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- W2915459040 doi "https://doi.org/10.1016/j.microc.2019.02.063" @default.
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