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High-performance liquid chromatography method for the quantification of pantoprazole in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Aug 05; 822(1-2):326-9.JC

Abstract

A sensitive and selective HPLC method with UV detection (290 nm) was developed and validated for quantitation of pantoprazole, proton-pump inhibitor, in human plasma. Following a single-step liquid-liquid extraction with methyl tert-butyl ether/diethyl ether (70/30, v/v), the analyte and internal standard (zonisamide) were separated using an isocratic mobile phase of 10mM phosphate buffer (pH 6.0)/acetonitrile (61/39, v/v) on reverse phase Waters symmetry C18 column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 4%. A linear range of 20-5000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 1.3-3.2% and 0.7-3.3%, respectively. The between-batch and within-batch bias was -0.5 to 8.2 % and -2.5 to 12.1%, respectively. This validated method is sensitive and repeatable enough to be used in pharmacokinetic studies.

Authors+Show Affiliations

Ramakrishna NV
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Banjara Hills, Hyderabad 500034, India. nvsrk@suven.com
Vishwottam KN
No affiliation info available
Wishu S
No affiliation info available
Koteshwara M
No affiliation info available

MeSH

2-PyridinylmethylsulfinylbenzimidazolesBenzimidazolesChromatography, High Pressure LiquidHumansOmeprazolePantoprazoleReproducibility of ResultsSensitivity and SpecificitySulfoxidesUltraviolet Rays

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

16005696

Citation

Ramakrishna, N V S., et al. "High-performance Liquid Chromatography Method for the Quantification of Pantoprazole in Human Plasma." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 822, no. 1-2, 2005, pp. 326-9.
Ramakrishna NV, Vishwottam KN, Wishu S, et al. High-performance liquid chromatography method for the quantification of pantoprazole in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2005;822(1-2):326-9.
Ramakrishna, N. V., Vishwottam, K. N., Wishu, S., & Koteshwara, M. (2005). High-performance liquid chromatography method for the quantification of pantoprazole in human plasma. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 822(1-2), 326-9.
Ramakrishna NV, et al. High-performance Liquid Chromatography Method for the Quantification of Pantoprazole in Human Plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Aug 5;822(1-2):326-9. PubMed PMID: 16005696.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-performance liquid chromatography method for the quantification of pantoprazole in human plasma. AU - Ramakrishna,N V S, AU - Vishwottam,K N, AU - Wishu,S, AU - Koteshwara,M, PY - 2005/01/26/received PY - 2005/06/07/revised PY - 2005/06/09/accepted PY - 2005/7/12/pubmed PY - 2005/10/1/medline PY - 2005/7/12/entrez SP - 326 EP - 9 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 822 IS - 1-2 N2 - A sensitive and selective HPLC method with UV detection (290 nm) was developed and validated for quantitation of pantoprazole, proton-pump inhibitor, in human plasma. Following a single-step liquid-liquid extraction with methyl tert-butyl ether/diethyl ether (70/30, v/v), the analyte and internal standard (zonisamide) were separated using an isocratic mobile phase of 10mM phosphate buffer (pH 6.0)/acetonitrile (61/39, v/v) on reverse phase Waters symmetry C18 column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 4%. A linear range of 20-5000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 1.3-3.2% and 0.7-3.3%, respectively. The between-batch and within-batch bias was -0.5 to 8.2 % and -2.5 to 12.1%, respectively. This validated method is sensitive and repeatable enough to be used in pharmacokinetic studies. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/16005696/High_performance_liquid_chromatography_method_for_the_quantification_of_pantoprazole_in_human_plasma_ DB - PRIME DP - Unbound Medicine ER -