Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin

Journal of Chromatographic Science

Volumn 50, Issue 9, 2012, Pages 831-838

  Silva, Taízia D ^a   Oliveira, Marcelo A ^a   De Oliveira, Renata B ^a   Vianna Soares, Cristina D ^a  

^a FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; MEVINOLIN; NAPHTHALENE DERIVATIVE; PRAVASTATIN; SIMVASTATIN;

ARTICLE; CHEMISTRY; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STATISTICAL MODEL;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; LINEAR MODELS; LOVASTATIN; NAPHTHALENES; PRAVASTATIN; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SIMVASTATIN;

EID: 84867760158     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chromsci/bms079     Document Type: Article

References (23)

1. Goodman, L., Gilman, A.; The pharmacological basis of therapeutics. 10th edition, McGraw-Hill, Rio de Janeiro, (2003), pp. 739-744.
2. Ertürk, S., Önal, A., Çetin, S.; Analytical methods for the quantitative determination of 3-hidroxy-3-methylglutaryl coenzyme A reductase inhibitors in biological samples; Journal of Chromatography B, (2003); 793: 193-205. (Pubitemid 37271960)
3. Nirogi, R., Mudigonda, K., Kandikere, V.; Chromatography-mass spectrometry methods for the quantification of statins in biological samples; Journal of Pharmaceutical and Biomedical Analysis, (2007); 44: 379-387. (Pubitemid 46887638)
4. Zhao, J.J., Xie, I.H., Yang, A.Y., Roadcap, B.A., Rogers, J.D.; Quantitation of simvastatin and its b-hydroxy acid in human plasma by liquid-liquid cartridge extraction and liquid chromatography/ tandem mass spectrometry; Journal of Mass Spectrometry, (2000); 35: 1133-1143.
5. Arayne, M.S., Sultana, N., Hussain, F., Ali, S.A.; Validated spectrophotometric method for quantitative determination of simvastatin in pharmaceutical formulation and human serum; Journal of Analytical Chemistry, (2007); 62: 536-541. (Pubitemid 46965642)
6. Basavaiah, K., Devi, O.Z.; Cerimetric determination of simvastatin in pharmaceuticals based on redox and complex formation reactions; Eclética Quimica, (2008); 33: 21-28.
7. Basavaiah, K., Tharpa, K.; The development and validation of visible spectrophotometric methods for simvastatin determination in pure and tablet dosage forms; Chemical Industry and Chemical Engineering Quarterly, (2008); 14: 205-210.
8. Gomes, F.P., Garcia, P.L., Alves, J.M.P., Singh, A.K., Kedor-Hackmann, E.R.M., Santoro, M.I.R.M.; UV-derivative spectrophotometric and stability-indicating high-performance liquid chromatographic methods for determination of simvastatin in tablets; Latin American Journal of Pharmacy, (2009); 28: 261-269.
9. Wang, L., Asgharnejad, M.; Second-derivative UV spectrometric determination of simvastatin in its tablet dosage form; Journal of Pharmaceutical and Biomedical Analysis, (2000); 21: 1243-1248. (Pubitemid 30001553)
10. British Pharmacopoeia. The Stationary Office, London, UK, (2010), pp. 1298, 1746, 1893, 3023, 3080.
11. European Pharmacopoeia. Supplement 6.6, 6th edition, Directorate of Quality of Medicines of the Council of Europe, France, (2010), pp. 5279-5318.
12. European Pharmacopoeia. Supplement 6.4, 6th edition, Directorate of Quality of Medicines of the Council of Europe, France, (2009), p. 4686.
13. United States Pharmacopeia, 32 rev. National Formulary, 32 rev. United States Pharmacopeial Convention, Rockville, MD, (2009), pp. 3081, 3645, 3855.
14. Japanese Pharmacopoeia. 15th edition, Society of Japanese Pharmacopoeia, Japan, (2006), p. 1018.
15. Green, J.; A practical guide to analytical method validation; Analytical Chemistry, (1996); 68: 305A-309A.
16. United States Food and Drug Administration (US/FDA). Guidance for industry, bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration, Rockville, MD, (2001).
17. International Conference on Harmonisation (ICH). Guidance for Industry. Q2B Validation of Analytical Procedures: Methodology. Food and Drug Administration, Rockville, MD, 1996.
18. Bakshi, M., Singh, S.; Development of validated stability-indicating assay methods-critical review; Journal of Pharmaceutical and Biomedical Analysis, (2002); 28: 1011-1040. (Pubitemid 34607392)
19. Snyder, L.R., Kirkland, J.J., Geajch, J.L.; Practical HPLC method development, 2nd edition, John Wiley & Sons, New York, NY, (1997), pp. 685-713.
20. United States Food and Drug Administration (USFDA). Reviewer guidance validation of chromatographic methods. Center for Drug Evaluation and Research (CDER), Rockville, MD, (1994).
21. Önal, A., Sagirli, O.; Development of a selective LC method for the determination of pravastatin sodium; Chromatographia, (2006); 64: 157-162. (Pubitemid 44258069)
22. Alvarez-Lueje, A., Pastine, J., Squella, J.A., Nunez-Vergara, L.J.; Assessment of the hydrolytic degradation of lovastatin by HPLC; Journal of the Chilean Chemical Society, (2005); 50: 639-646. (Pubitemid 43668196)
23. Yang, D., Hwang, L.S.; Study on the conversion of three natural statins from lactone forms to their corresponding hydroxy acid forms and their determination in Pu-Erh tea; Journal of Chromatography A, (2006); 1119: 277-284. (Pubitemid 43831894)