Development and validation of high performance liquid chromatographic method for the determination of esomeprazole in tablets

Journal of Food and Drug Analysis

Volumn 14, Issue 1, 2006, Pages 12-18

  Önal, Armaǧan ^a   Öztunç, Aysel ^a  

^a ISTANBUL UNIVERSITY   (Turkey)

Author keywords

Esomeprazole; HPLC; Stability indicating; Tablet assay; Validation

Indexed keywords

ACETONITRILE; ESOMEPRAZOLE; LANSOPRAZOLE; PHOSPHATE BUFFERED SALINE;

ACCURACY; ARTICLE; CALIBRATION; CONTROLLED STUDY; DRUG DETERMINATION; DRUG HYDROLYSIS; DRUG OXIDATION; DRUG QUALITY; DRUG STABILITY; DRUG STRUCTURE; FLOW RATE; HEAT TREATMENT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; PHOTODEGRADATION; STANDARD; TABLET; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS;

EID: 33646741568     PISSN: 10219498     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. Tonini, M., Vigneri, S., Savarino, V. and Scarpignato, C. 2001. Clinical pharmacology and safety profile of esomeprazole, the first enantiomerically pure proton pump inhibitor. Dig. Liver Dis. 33: 600-606.
2. Kale-Pradhan, P. B., Landry, H. K. and Sypula, W. T. 2002. Esomeprazole for acid peptic disorders. Ann. Pharmacotheraphy 36: 655-663.
3. Luga, C. Bojita, M. Hudrea, F. and Miron, M. 1997. Ouantitative determination of omeprazole in bulk and in pharmaceuticals. Farmacia (Bucharest) 45: 43-51.
4. Salama, F., El-Abasawy, N., Abdel Razeq, S. A., Ismail, M. M. F. and Fouad, M. M. 2003. Validation of the spectrophotometric determination of omeprazole and pantoprazole sodium via their metal chelates. J. Pharm. Biomed. Anal. 33: 411-421.
5. Wahbi, A-A. M., Abdel-Razak, O., Gazy, A. A., Mahgoub, H. and Moneeb, M. S. 2002. Spectrophotometric determination of omeprazole, lansoprazole and pantoprazole in pharmaceutical formulations. J. Pharm. Biomed. Anal. 30: 1133-1142.
6. Karljikovic-Rajic, K., Novovic, D., Marinkovic, V. and Agbaba, D. 2003. First-order UV-derivative spectrophotometry in the analysis of omeprazole and pantoprazole sodium salt and corresponding impurities. J. Pharm. Biomed. Anal. 32: 1019-1027.
7. Castro, D., Moreno, M. A., Torrado, S. and Lastres, J. L. 1999. Comparison of derivative spectrophotometric and liquid chromatographic methods for the determination of omeprazole in aqueous solutions during stability studies. J. Pharm. Biomed. Anal. 21: 291-298.
8. Ruiz, M. A., Reyes, I., Parera, A. and Gallardo, V. 1998. Determination of the stability of omeprazole by means of differential scanning calorimetry. J. Therm. Anal. Calorim. 51: 29-35.
9. Ekpe, A. and Jacobsen, T. 1999. Effect of various salts on the stability of lansoprazole, omeprazole, and pantoprazole as determined by high-performance liquid chromatography. Drug Dev. Ind. Pharm. 25: 1057-1065.
10. Nevado, J. J. B. G. C., Peñlvo, R. M. and Dorado, R. 2004. Method development and validation for the separation and determination of omeprazole enantiomers in pharmaceutical preparations by capillary electrophoresis. Anal. Chim. Acta. (In Press)
11. United States Pharmacopeia and National Formulary (USP 27/NF 22). 2004. pp. 1358-1359. The US Pharmacopeial Convention. Rockville, MD, U. S. A.
12. British Pharmacopeia. 2004. Vol. II. pp. 1428-1429. Her Majesty's Stationery Office. London, U. K.
13. Cass, Q. B., Lima, V. V., Oliveira, R. V., Cassiano, N. M., Degani, A. L. G. and Pedrazzoli, J. 2003. Enantiomeric determination of the plasma levels of omeprazole by direct plasma injection using high-performance liquid chromatography with a chiral-chiral column-switching. J. Chromatogr. B 798: 275-281.
14. Kanazawa, H., Okada, A., Matsushima, Y., Yokota, H., Okubo, S., Mashige, F. and Nakahara, K. 2002. Determination of omeprazole and its metabolites in human plasma by liquid chromatography-mass spectrometry. J. Chromatogr. A 949: 1-9.
15. Cheng, F. C., Ho, Y. F., Hung, L. C., Chen, C. F. and Tsai, T. H. 2002. Determination and pharmacokinetic profile of omeprazole in rat blood, brain and bile by microdialysis and high-performance liquid chromatography. J. Chromatogr. A 949: 35-42.
16. Ávarez-Lueje, A., Pujol, S., Squella, J. A. and Nunez-Vergara, L. J. 2003. A selective HPLC method for determination of lercanidipine in tablets. J. Pharm. Biomed. Anal. 31: 1-9.
17. Abdul-Fattah. A. M. and Bhargava, H. N. 2002. A new high-performance liquid chromatography (HPLC) method for the analysis of halofantrine (HF) in pharmaceuticals. J. Pharm. Biomed. Anal. 29: 901-908.
18. Lambropoulos, J., Spanos, G. A. and Lozaridis, V. N. 1999. Method development and validation for the HPLC assay (potency and related substances) for 20 mg paroxetine tablets. J. Pharm. Biomed. Anal. 19: 793-802.
19. Bebawy, L. I. 2003. Spectrophotometric and HPLC determination of linezolid in the presence of its alkaline-induced degradation products and in pharmaceutical tablets. Anal. Let. 36: 1147-1161.
20. Kelani, K. M., Aziz, A. M., Hegazy, M. A. and Fattah, L. A. 2002. UV-spectrophotometric stability indicating methods for the quantitative determination of cimetidine, famotidine, and ranitidine hydrochloride in the presence of their oxidative. Anal. Let. 35: 1055-1073
21. 2002 ICH, Q1A Stability Testing of New Drug Substances and Products. October 1993. International Conference on Harmonization. Geneva.