Simultaneous estimation of four proton pump inhibitors - Lansoprazole, omeprazole, pantoprazole and rabeprazole: Development of a novel generic HPLC-UV method and its application to clinical pharmacokinetic study

Biomedical Chromatography

Volumn 23, Issue 7, 2009, Pages 732-739

  Bharathi, D Vijaya ^a,b   Hotha, Kishore Kumar ^a   Jagadeesh, B ^a   Chatki, Pankaj K ^a   Thriveni, K ^a   Mullangi, Ramesh ^c   Naidu, A ^b  

^a DR REDDY'S LABORATORIES LTD   (India)

^b JNTUH COLLEGE OF ENGINEERING   (India)

^c Jubilant Innovation   (India)

Author keywords

HPLC; Human plasma; Lansoprazole; Omeprazole; Pantoprazole; Pharmacokinetics; Proton pump inhibitors; Rabeprazole; Validation

Indexed keywords

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PLASMA (HUMAN);

HPLC; HUMAN PLASMAS; INTERNAL STANDARDS; LANSOPRAZOLE; OMEPRAZOLE; PANTOPRAZOLE; PHARMACOKINETIC STUDIES; PROTON-PUMP INHIBITORS; RABEPRAZOLE; VALIDATION;

PHARMACOKINETICS;

LANSOPRAZOLE; OMEPRAZOLE; PANTOPRAZOLE; PROTIUM; RABEPRAZOLE; UNCLASSIFIED DRUG; 2 [[(2 PYRIDYL)METHYL]SULFINYL]BENZIMIDAZOLE DERIVATIVE; ISOXAZOLE DERIVATIVE; PROTON PUMP; ZONISAMIDE;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG HALF LIFE; DRUG METABOLISM; DRUG STRUCTURE; ELUTION; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID LIQUID EXTRACTION; MALE; MAXIMUM PLASMA CONCENTRATION; SENSITIVITY AND SPECIFICITY; TIME TO MAXIMUM PLASMA CONCENTRATION; BLOOD; CHEMISTRY; DRUG ANTAGONISM; DRUG STABILITY; METHODOLOGY; REPRODUCIBILITY; ULTRAVIOLET SPECTROPHOTOMETRY;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HUMANS; ISOXAZOLES; MALE; OMEPRAZOLE; PROTON PUMPS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 70149083287     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1177     Document Type: Article

References (20)

1. Aoki I, Okumura M and Yashiki T. High-performance liquid chromatographic determination of lansoprazole and its metabolites in human serum and urine. Journal of Chromatography 1991; 571: 283-290.
2. Berardi RR. A critical evaluation of proton pump inhibitors in the treatment of gastro-oesophageal reflux disease. The American Journal of Managed Care 2000; 6: S491-S505.
3. Ekpe A and Jacobsen T. Effect of various salts on the stability of lansoprazole, omeprazole, and pantoprazole as determined by high-performance liquid chromatography. Drug Development and Industrial Pharmacy 1999; 25: 1057-1065.
4. Hofmann U, Schwab M, Treiber G and Klotz U. Sensitive quantification of omeprazole and its metabolites in human plasma by liquid chromatography-mass spectrometry. Journal of Chromatography B 2006; 831: 85-90.
5. Huber R, Kohl B, Sachs G, Senn-Bilfinger J, Simon WA and Sturm E. Review article: the continuing development of proton pump inhibitors with particular reference to pantoprazole. Alimentary Pharmacology & Therapeutics 1999; 9: 363-378.
6. Katsuki H, Hamada A, Nakamura C, Arimori K and Nakano M. High-performance liquid chromatographic assay for the simultaneous determination of lansoprazole enantiomers and metabolites in human liver microsomes. Journal of Chromatography B 2001; 757: 127-133.
7. Kobayashi K, Chiba K, Sohn DR, Kato Y and Ishizaki T. Simultaneous determination of omeprazole and its metabolites in plasma and urine by reversed-phase high-performance liquid chromatography with an alkaline-resistant polymer-coated C18 column. Journal of Chromatography 1992; 579: 299-305.
8. Landes BD, Miscoria G and Flouvat B. Determination of lansoprazole and its metabolites in plasma by high-performance liquid chromatography using a loop column. Journal of Chromatography 1992; 577: 117-122.
9. Mihaly GW, Prichard PJ, Smallwood RA, Yeomans ND and Louis WJ. Simultaneous high-performance liquid chromatographic analysis of omeprazole and its sulphone and sulphide metabolites in human plasma and urine. Journal of Chromatography 1983; 278: 311-319.
10. Miura M, Tada H, Satosh S, Habuchi T and Suzuki T. Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction. Journal of Pharmaceutical and Biomedical Analysis 2006; 41: 565-570.
11. Miura M, Tada H and Suzuki T. Simultaneous determination of lansoprazole enantiomers and their metabolites in plasma by liquid chromatography with solid-phase extraction. Journal of Chromatography B 2004; 804: 389-395.
12. Rezk NL, Brown KC and Kashuba AD. A simple and sensitive bioanalytical assay for simultaneous determination of omeprazole and its three major metabolites in human blood plasma using RP-HPLC after a simple liquid-liquid extraction procedure. Journal of Chromatography B 2006; 844: 314-321.
13. Richardson P, Hawkey CJ and Stack WA. Proton pump inhibitors: pharmacology and rationale for use in gastrointestinal disorders. Drugs 1998; 56: 307-335.
14. +ATPase. Annual Review of Pharmacology and Toxicology 1995; 35: 277-305.
15. Shimizu M, Uno T, Niioka T, Yaui-Furukori N, Takahat T, Sugawara K and Tateishi T. Sensitive determination of omeprazole and its two main metabolites in human plasma by column-switching high-performance liquid chromatography: application to pharmacokinetic study in relation to CYP2C19 genotypes. Journal of Chromatography B 2006; 832: 241-248.
16. Stedman CA and Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Alimentary, Pharmacology and Therapy 2000; 14: 963-978.
17. Uno T, Yasui-Furukori N, Takahata T, Sugawara K and Tateishi T. Determination of lansoprazole and two of its metabolites by liquid-liquid extraction and automated column-switching high-performance liquid chromatography: application to measuring CYP2C19 activity. Journal of Chromatography B 2005a; 816: 309-314.
18. Uno T, Yasui-Furukori N, Shimizu M, Sugawara K and Tateishi T. Determination of rabeprazole and its active metabolite, rabeprazole thioether in human plasma by column-switching high-performance liquid chromatography and its application to pharmacokinetic study. Journal of Chromatography B 2005b; 824: 238-243.
19. US DHHS, FDA, CDER. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Veterinary Medicine, 2001. Available at: http://www.fda.gov/cder/ guidance/index.htm
20. Xie Z, Chen X, Jin F and Zhong D. Simultaneous determination of pantoprazole and its two metabolites in dog plasma by HPLC. Journal of Chromatographic Science 2005; 43: 271-275.