Abstract
A simple and robust high-performance liquid chromatography (HPLC) method is described for the assay for levetiracetam (LTC), methyl paraben (MHB), and propyl paraben (PHB) either in their pure form or in commercial Levepsy® syrup. The method is selective and stability indicating and all chromatographic conditions were studied to obtain adequate separation of LTC, MHB, and PHB from their degradation products and from excipients. The HPLC separation was carried out on a RP C18 Hypersil BDS analytical column (150 mm × 4.6 mm ID) using gradient elution system. The mobile phase flow rate was 1.5 mLmin−1 and the column temperature was kept at 40°C. Complete separation of the studied components was obtained within a cycle time of 8 min. LTC, MHB, and PHB were eluted at 1.56, 5.86, and 7.85 min, respectively. Detection was carried out at 240 nm using a dual wavelength detector. The method has been validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantitation, robustness, and ruggedness. The proposed method was successfully applied for the determination of LTC in the presence of parabens in Levepsy syrup.
Highlights
Levetiracetam (LTC) is an important antiepileptic drug that is used as a monotherapy or in combination with other drugs in patients who suffered from partial and secondary generalized seizures [1]
Few high-performance liquid chromatography (HPLC) procedures have been developed for LTC determination in biological fluid and in tablet formulation using either mass spectrometry or UV detection [2,3,4,5,6,7] or capillary electrophoresis [8]
It is very important to determine parabens in formulations to be sure that their concentrations do not exceed the limit specified by the International Conference on Harmonization (ICH) guidelines (ICH 2005) [11]
Summary
Levetiracetam (LTC) is an important antiepileptic drug that is used as a monotherapy or in combination with other drugs in patients who suffered from partial and secondary generalized seizures [1]. Few HPLC procedures have been developed for LTC determination in biological fluid and in tablet formulation using either mass spectrometry or UV detection [2,3,4,5,6,7] or capillary electrophoresis [8]. Parabens are widely used as preservatives in industrial pharmacy. They are commonly used due to their bactericidal and fungicidal properties. No published HPLC method was developed for the determination of parabens with levetiracetam. The development of a robust and selective analytical HPLC method would be necessary for determination of methyl and propyl parabens with levetiracetam in either pure form or syrup as an example of pharmaceutical formulation
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