Rasagiline hemitartrate: Synthesis, characterization and RP-HPLC validation for its estimation in bulk form

Drug Invention Today

Volumn 5, Issue 2, 2013, Pages 133-138

  Sudhir, Muvvala S ^a   Venkata Nadh, Ratnakaram ^b  

^a Sri Subbaraya and Narayana College   (India)

^b VIGNAN UNIVERSITY   (India)

Author keywords

Characterization; Rasagiline hemitartrate; RP HPLC method; Synthesis; Validation

Indexed keywords

ACETONITRILE; BUFFER; METHANOL; POTASSIUM DIHYDROGEN ORTHOPHOSPHATE BUFFER; RASAGILINE; RASAGILINE HEMITARTRATE; UNCLASSIFIED DRUG;

ANALYTICAL PARAMETERS; ARTICLE; BULK FORM; CHEMICAL ANALYSIS; CONTROLLED STUDY; CORRELATION COEFFICIENT; DRUG DOSAGE FORM; DRUG RETENTION; DRUG STRUCTURE; DRUG SYNTHESIS; ELEMENTAL ANALYSIS; FLOW RATE; INFRARED SPECTROSCOPY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEAR SYSTEM; MASS SPECTROMETRY; MEASUREMENT ACCURACY; PH; PROTON NUCLEAR MAGNETIC RESONANCE; QUANTITATIVE ANALYSIS; RELIABILITY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ROBUSTNESS; RUGGEDNESS; ULTRAVIOLET SPECTROSCOPY; VALIDATION STUDY;

EID: 84880945678     PISSN: 09757619     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.dit.2013.05.002     Document Type: Article

References (25)

1. Chen J.J., David M.S., Khashayar D. Comprehensive review of rasagiline, a second-generation monoamine oxidase inhibitor, for the treatment of Parkinson's disease. Cli Therapeutics 2007, 29:1825-1849.
2. Kathirvel S., Satyanarayana S.V., Devala Rao G. Development and validation of a stability-indicating HPTLC method for analysis of rasagiline mesylate in the bulk drug and tablet dosage form. Chr Res Int 2012, 1:1-6.
3. Peskin TB. Teva pharmaceutical Industries Ltd, Jerusalem,- rasagiline formulations of improved content uniformity, United States Patent 20060188581, Filed on 22-02-2006, Published on 24-08-2006.
4. Thebault J.J., Guillaume M., Levy R. Tolerability, safety, pharmacodynamics, and pharmacokinetics of rasagiline: a potent, selective, and irreversible monoamine oxidase type B inhibitor. Pharmacotherapy 2004, 24:1295-1305.
5. Tatton W.G., Wadia J.S., Ju W.Y., Chalmers-Redman R.M., Tatton N.A. (-)-Deprenyl reduces neuronal apoptosis and facilitates neuronal outgrowth by altering protein synthesis without inhibiting monoamine oxidase. J Neu Transm Supp 1996, 48:45-59.
6. Youdim M.B.H., Aviva G., John F.P.M. Rasagiline [N-propargyl-1R (+)-aminoindan], a selective and potent inhibitor of mitochondrial monoamine oxidase B. Br J Pharmac 2001, 132:500-506.
7. Olanow C.W. Rationale for considering that propargylamines might be neuroprotective in Parkinson's disease. Neurology 2006, 66:S69-S79.
8. Devala Rao G., Kathirvel S., Satyanarayana S.V. Simple spectrophotometric methods for the determination of rasagiline mesylate in pharmaceutical dosage form. J Pharm Res 2011, 4:61-62.
9. Chennaiah M., Veeraiah T., Charan Singh T., Venkateshwarlu G. Extractive spectrophotometry methods for determination of rasagiline mesylate in pharmaceutical formulations using acidic triphenylmethane dyes. J Chi Che Soc 2011, 56:926-929.
10. Rama R., Preeti K. UV spectrophotometric method for the determination of rasagiline mesylate in bulk and pharmaceutical formulations. Int J Pharma Sci Rev Res 2010, 5:5-7.
11. Kumar R.J., Jeyabaskaran M., Kumari P.M. Validated RP -HPLC method for the estimation of rasagiline in pure and tablet dosage form. J Pharm Res 2011, 5:1376-1377.
12. Kumar R.N., Rao G.N., Naidu P.Y. Stability indicating RP-LC method for determination of rasagiline mesylate in bulk and pharmaceutical dosage forms. Int J App Bio Pharma Tech 2010, 1:247-259.
13. Sundaramurthy P., Balaji V., Rajasekhara R., Raju I. Validated and stability indicating dissolution test with RP-HPLC analysis for rasagiline mesylate in tablet dosage form. Int J Pharm Sci Rev Res 2011, 10:18-23.
14. Lakshmi M.V., Rao J.V.L.N.S., Rao A.L. Development and validation of RP-HPLC method for the estimation of rasagiline tablet dosage forms. RASĀYAN J Chem 2010, 3:621-624.
15. Fernández M., Barcia E., Negro S. Development and validation of a reverse phase liquid chromatography method for the quantification of rasagiline mesylate in biodegradable PLGA microspheres. J Pharm Biomed Anal 2009, 49:1185-1191.
16. Reddy K.U., Sriramulu J., Reddy U.M., Reddy Y.P. Stability indicating RP-HPLC method for the determination of rasagiline in pharmaceutical products. Int J Sci Inn Disc 2011, 1:19-32.
17. Song M., Wang L., Zhao H., et al. Rapid and sensitive liquid chromatography-tandem mass spectrometry: assay development, validation and application to a human pharmacokinetic study. J Chromatogr B, Anal Tech Biomed Life Sci 2008, 875:515-521.
18. Ma J., Chen X., Duan X., Deng P., Wang H., Zhong D. Validated LC-MS/MS method for quantitative determination of rasagiline in human plasma and its application to a pharmacokinetic study. J Chromatogr B 2008, 873:203-208.
19. Rao N.V.S.M., Rao M.C., Biju B., et al. Validated LC-MS/MS method for quantitative determination of rasagiline in human plasma and its application to a pharmacokinetic study. J Chromatogr B 2010, 863:215-222.
20. Youdim MBH, Finberg JPM, Levy R, etal. Teva Pharmaceutical Industries Ltd, Jerusalem, Application Number 08/411,398, Filed on 28-03-1995, Published on 02-07-1996, R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof, United State Patent 5,532,415 (1996).
21. Peskin TB, Caciularu F. Teva Pharmaceutical Industries Ltd, Jerusalem, Application Number 96/00115, Filed on 18-09-1996, Published on 10-04-1997, Stable compositions containing N-propargyl-1-aminoindan, United States Patent 6,126,968 (1997).
22. Stephen BDW, Ernesto DL, Monica BV. Application Number 12/505,612, Filed on 20-07-2009, Published on 18-02-2010, New salt forms of an aminoindan derivative, United States Patent 20100041920 (2010).
23. The United States Pharmacopoeia 2007, United States Pharmacopoeial Convention Inc, Rockville, USA. 30th ed.
24. Kemp W. Organic Spectroscopy 1991, Palgrave, New York. 3rd ed.
25. Isabel T., Marc D.L., Erik V.B. Trends in quality in the analytical laboratory- II-analytical method validation and quality assurance. Tr Ana Che 2004, 23:535-552.