A validated chiral liquid chromatographic method for the enantiomeric separation of safinamide mesilate, a new anti-Parkinson drug

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 1, 2011, Pages 220-224

  Zhang, Kai ^a   Xue, Na ^b   Shi, Xiaowei ^a   Liu, Weina ^a   Meng, Jing ^a   Du, Yumin ^a  

^a HEBEI MEDICAL UNIVERSITY   (China)

^b Heibei Chemical and Pharmaceutical College ^*  (China)

Author keywords

Chiral HPLC; Chiralcel OD RH; Monoamino oxidase type B inhibitor; Parkinson disease; Safinamide mesilate

Indexed keywords

ACETONITRILE; ANTIPARKINSON AGENT; METHANOL; SAFINAMIDE; SODIUM DIHYDROGEN PHOSPHATE;

ACCURACY; ACIDITY; ANTICONVULSANT ACTIVITY; ARTICLE; CHIRALITY; DRUG DETERMINATION; ENANTIOMER; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PARKINSON DISEASE; PRIORITY JOURNAL; REPRODUCIBILITY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

ALANINE; ANTIPARKINSON AGENTS; BENZYLAMINES; CALIBRATION; CELLULOSE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; DRUG STABILITY; HYDROGEN-ION CONCENTRATION; LIMIT OF DETECTION; MESYLATES; MONOAMINE OXIDASE INHIBITORS; PARKINSON DISEASE; PHENYLCARBAMATES; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; STEREOISOMERISM; TECHNOLOGY, PHARMACEUTICAL;

EID: 79951767227     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.12.030     Document Type: Article

References (15)

1. Espinosa Bosch M., Ruiz Sánchez A.J., Sánchez Rojas F., Bosch Ojeda C. Recent advances in analytical determination of thalidomide and its metabolites. J. Pharm. Biomed. Anal. 2008, 46:9-17.
2. Caner H., Groner E., Levy L. Trends in the development of chiral drugs. Drug. Discov. Today 2004, 9:105-110.
3. Caldwell J. Importance of stereospecific bioanalytical monitoring in drug development. J. Chromatogr. A 1996, 719:3-13.
4. Maier N.M., Franco P., Lindner W. Separation of enantiomers: needs, challenges, perspectives. J. Chromatogr. A 2001, 906:3-33.
5. Pathare D.B., Jadhav A.S., Shingare M.S. Validated chiral liquid chromatographic method for the enantiomeric separation of pramipexole dihydrochloride monohydrate. J. Pharm. Biomed. Anal. 2006, 41:1152-1156.
6. Nageswara Rao R., Narasa Raju A., Nagaraju D. Development and validation of a liquid chromatographic method for determination of enantiomeric purity of citalopram in bulk drugs and pharmaceuticals. J. Pharm. Biomed. Anal. 2006, 41:280-285.
7. Srinivasu M.K., Mallikarjuna Rao B., Shyam Sundar Reddy B., Rajeneder Kumar P., Chandrasekhar K.B., Mohakhud P.K. A validated chiral liquid chromatographic method for the enantiomeric separation of Rivastigmine hydrogen tartarate, a cholinesterase inhibitor. J. Pharm. Biomed. Anal. 2005, 38:320-325.
8. Ali I., Gaitonde V.D., Aboul-Enein H.Y., Hussain A. Chiral separation of β-adrenergic blockers on CelluCoat column by HPLC. Talanta 2009, 78:458-463.
9. Fariello R.G. Safinamide. Neurotherapeutics 2007, 4:110-116.
10. Marzo A., Dal Bo L., Ceppi Monti N., Crivelli F., Ismaili S., Caccia C., Cattaneo C., Fariello R.G. Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity. Pharmacol. Res. 2004, 50:77-85.
11. Stocchi F., Vacca L., Grassini P., De Pandis M.F., Battaglia G., Cattaneo C., Fariello R.G. Symptom relief in Parkinson disease by safinamide. Neurology 2006, 67:S24-S29.
12. Onofrj M., Bonanni L., Thomas A. An expert opinion on safinamide in Parkinson's disease. Expert Opin. Investig. Drugs 2008, 17:1115-1125.
13. Pevarello P., Bonsignori A., Dostert P., Heidempergher F., Pinciroli V., Colombo M., McArthur R.A., Salvati P., Post C., Fariello R.G., Varasi M. Synthesis and anticonvulsant activity of a new class of 2-[(arylalkyl)amino] alkanamide derivatives. J. Med. Chem. 1998, 41:579-590.
14. Dal Bo L., Mazzucchelli P., Fibbioli M., Marzo A. Bioassay of safinamide in biological fluids of humans and various animal species. Arzneimittel Forschung 2006, 56:814-819.
15. ICH draft Guidelines on Validation of Analytical Procedures: Definitions and Terminology, Federal Register 1995, vol. 60. IFPMA, Switzerland, pp. 11260-11268.