SEPARATION AND ESTIMATION OF PROCESS RELATED IMPURITIES AND DEGRADATION PRODUCTS OF LEVETIRACETAM IN SOLID PHARMACEUTICAL FORMULATION USING ION-PAIR CHROMATOGRAPHY

REFERENCES

• U.S. Food and Drug Administration. Drug Approval Package Keppra (Levetiracetam) Tablets NDA 21035, 1999. http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21035_Keppra.cfm (Accessed March 2011)
   Google Scholar
• www.Rxlist.com/cgi/generic3/keppra.htm
   Google Scholar
• Reddy , T. S. ; Devi , P. S. Validation of a High-Performance Thin-Layer Chromatographic Method with Densitometric Detection for Quantitative Analysis of Two Anticonvulsants in Tablets . J. Plan. Chromatogr. 2007 , 20 , 451 – 456 .
   Web of Science ®Google Scholar
• Ivanova , M. ; Piunti , A. ; Marziali , E. ; Komarova , N. ; Raggi , M. A. ; Kenndler , E. Microemulsion Electrokinetic Chromatography Applied for Separation of Levetiracetam from Other Antiepileptic Drugs in Polypharmacy . Electrophoresis. 2003 , 24 , 992 – 998 .
   PubMed Web of Science ®Google Scholar
• Shihabi , Z. K. ; Oles , K. ; Hinsdale , M. Analysis of the Antiepileptic Drug Keppra by Capillary Electrophoresis . J. Chromatogr A. 2003 , 1004 , 9 – 12 .
   PubMed Web of Science ®Google Scholar
• Martens-Lobenhoffer , J. ; Bode-Boger , S. M. Determination of Levetiracetam in Human Plasma with Minimal Sample Pretreatment . J. Chromatogr. B. 2005 , 819 , 197 – 200 .
   PubMed Web of Science ®Google Scholar
• Matar , K. M. Quantification of Levetircetam in Human Plasma by Liquid Chromatrography-Tandem Mass Spectroscopy: Application to Therapeutic Drug Monitoring . J. Pharm. Biomed. Anal. 2008 , 48 , 822 – 828 .
   PubMed Web of Science ®Google Scholar
• Jain , D. S. ; Subbaiah , G. ; Sanyal , M. ; Pal , U. ; Shrivastav , P. S. Determination of Levetiracetam in Human Plasma by Liquid Chromatography/Electrospray Tandem Mass Spectrometer and Its Application to Bioequivalence Studies . Rapid Commun. Mass Spectrom. 2006 , 20 , 2539 – 2547 .
   PubMed Web of Science ®Google Scholar
• Contin , M. ; Mohamed , S. ; Albani , F. ; Riva , R. ; Baruzzi , A. Simple and Validated HPLC- UV Analysis of Levetiracetam in Deproteinized Plasma of Patients with Epilepsy . J. Chromatogr. B. 2008 , 873 , 129 – 132 .
   PubMed Web of Science ®Google Scholar
• Can , N. O. ; Arli , G. Reversed-Phase HPLC Analysis of Levetiracetam in Tablets Using Monolithic and Conventional C18 Silica Columns . J. AOAC Internat. 2010 , 93 , 1 – 9 .
   PubMed Web of Science ®Google Scholar
• Valarmathy , J. ; Samueljoshua , L. ; Rathinavel , G. ; Thanuja , C. S. ; Sivakumar , T. RP-HPLC Method Development and Validation for Assay of Levetiracetam in Tablet Dosage Form . Research J. Pharm. and Tech. 2008 , 1 , 395 – 397 .
   Google Scholar
• Appala , R. N. ; Rao , J. V. ; Prakash , K. V. ; Mukkanti , K. ; Srinivasu , K. Estimation of Levetiracetam in Tablet Dosage Form by RP-HPLC . E-J. Chem. 2008 , 5 , 1098 – 1102 .
   Web of Science ®Google Scholar
• Rao , B. M. ; Rai , R. ; Reddy , B. S. S. ; Sivakumar , S. ; Chand , I. G. ; Kumar , K. P. ; Acharyulu , P. V. R. ; Reddy , G. O. ; Srinivasu , M. K. A Validated Chiral LC Method for the Enantioselective Analysis of Levetiracetam and Its Enantiomer R-α-ethyl-2-oxo-pyrrolidine Acetamide on Amylase-Based Stationary Phase. J. Pharm. Biomed. Anal. 2004, 35, 1017–1026.
   PubMed Web of Science ®Google Scholar
• U.S. Pharmacopeia. 32nd Ed., U.S. Pharmacopeial Convention, Rockville, MD, 2010.
   Google Scholar
• European Pharmacopeia, 7th Ed., European Directorate for Quality of Medicines, France, 2010.
   Google Scholar
• International Conference on Harmonization. (ICH) Q1A (R2), Stability Testing of New Drug Substances and Products, 2003, Geneva.
   Google Scholar
• International Conference on Harmonization. (ICH) Q1B, Photostability testing on new drug substances and products, 1996, Geneva.
   Google Scholar
• International Conference on Harmonization. (ICH) Q2 (R1), Validation of Analytical Procedures: Text and Methodology, 2005, Geneva.
   Google Scholar