LC Method for the Determination of the Stability of Levetiracetam Drug Substance under Stressing Conditions |
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Authors: | G Saravanan G Jyothi Y Suresh A Annerao M Ramakrishna M Yogeshwar Reddy B Ravibabu |
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Institution: | (1) Analytical Research, Matrix Laboratories Ltd, Hyderabad, 502325, India |
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Abstract: | Levetiracetam is used in combination with other medications to treat certain types of seizures in people with epilepsy. Levetiracetam
is in a class of medications called anticonvulsants and it works by decreasing abnormal excitement in the brain. A chromatographic
separation was achieved on a YMC pack ODS AQ, 250 mm × 4.6 mm, 5 μm column using diluted phosphoric acid and acetonitrile
in the ratio 85:15 v/v. Forced degradation studies were performed on the levetiracetam drug substance. The drug substance was degraded to Imp-B
during acid and base hydrolysis. When the stress samples were assayed, the mass balance was matching. The sample solution
and mobile phase was found to be stable up to 48 h at 25 °C. The developed method was validated with respect to linearity,
accuracy, precision and robustness. |
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Keywords: | Column liquid chromatography Solution and mobile phase stability Forced degradation Validation Levetiracetam |
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