Asian Journal of Research in Chemistry

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Development and Validation of an HPLC Method for Analysis of Levetiracetam in Human Plasma


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1 Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
     

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A simple Reverse Phase liquid chromatographic (HPLC) method for the determination of Levetiracetam in human plasma has been developed. Separation was achieved on a Prontosil C8 (150×4.6 mm, 5 μm) column with mobile phase composition of [pH 3.8 buffer:acetonitrile] (Solution A): HPLC grade water (Solution B) in the ratio 60:40 v/v with ultra violet detection at 210 nm. Lower limit of quantitation was 200 ng/ml. Maximum between-run precision was 5.91%. Mean extraction recovery was found to be 100.02 to 103.06%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 48h and at -20° for 2 months. Before injecting onto HPLC system, the processed samples were stable for at least 6 h. The method was used to perform bioequivalence study in human.
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  • Development and Validation of an HPLC Method for Analysis of Levetiracetam in Human Plasma

Abstract Views: 165  |  PDF Views: 0

Authors

G. V. H. Raju
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
S. Ganapathy
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
D. G. Sankar
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
P. Y. Naidu
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India

Abstract


A simple Reverse Phase liquid chromatographic (HPLC) method for the determination of Levetiracetam in human plasma has been developed. Separation was achieved on a Prontosil C8 (150×4.6 mm, 5 μm) column with mobile phase composition of [pH 3.8 buffer:acetonitrile] (Solution A): HPLC grade water (Solution B) in the ratio 60:40 v/v with ultra violet detection at 210 nm. Lower limit of quantitation was 200 ng/ml. Maximum between-run precision was 5.91%. Mean extraction recovery was found to be 100.02 to 103.06%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 48h and at -20° for 2 months. Before injecting onto HPLC system, the processed samples were stable for at least 6 h. The method was used to perform bioequivalence study in human.