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High-performance liquid chromatography method for the quantification of rabeprazole in human plasma using solid-phase extraction.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25; 816(1-2):209-14.JC

Abstract

A simple, sensitive and selective HPLC method with UV detection (284 nm) was developed and validated for quantitation of rabeprazole in human plasma, the newest addition to the group of proton-pump inhibitors. Following solid-phase extraction using Waters Oasistrade mark SPE cartridges, the analyte and internal standard (Pantoprazole) were separated using an isocratic mobile phase of 5 mM ammonium acetate buffer (pH adjusted to 7.4 with sodium hydroxide solution)/acetonitrile/methanol (45/20/35, v/v) on reverse phase Waters symmetry C(18) column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 8%. A linear range of 20-1000 ng/mL was established. This HPLC method was validated with between- and within-batch precision of 2.4-7.2% and 2.2-7.3%, respectively. The between- and within-batch bias was -1.7 to 2.6% and -2.6 to 2.1%, respectively. Frequently coadministered drugs did not interfere with the described methodology. Stability of rabeprazole in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 3 months storage in a freezer. This validated method is sensitive, simple and repeatable enough to be used in pharmacokinetic studies.

Authors+Show Affiliations

Ramakrishna NV
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Road #7, 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
Kumar SS
No affiliation info available

MeSH

2-PyridinylmethylsulfinylbenzimidazolesBenzimidazolesChromatography, High Pressure LiquidDrug StabilityHumansOmeprazoleRabeprazoleReproducibility of ResultsSensitivity and Specificity

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

15664352

Citation

Ramakrishna, N V S., et al. "High-performance Liquid Chromatography Method for the Quantification of Rabeprazole in Human Plasma Using Solid-phase Extraction." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 816, no. 1-2, 2005, pp. 209-14.
Ramakrishna NV, Vishwottam KN, Wishu S, et al. High-performance liquid chromatography method for the quantification of rabeprazole in human plasma using solid-phase extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2005;816(1-2):209-14.
Ramakrishna, N. V., Vishwottam, K. N., Wishu, S., Koteshwara, M., & Kumar, S. S. (2005). High-performance liquid chromatography method for the quantification of rabeprazole in human plasma using solid-phase extraction. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 816(1-2), 209-14.
Ramakrishna NV, et al. High-performance Liquid Chromatography Method for the Quantification of Rabeprazole in Human Plasma Using Solid-phase Extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25;816(1-2):209-14. PubMed PMID: 15664352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-performance liquid chromatography method for the quantification of rabeprazole in human plasma using solid-phase extraction. AU - Ramakrishna,N V S, AU - Vishwottam,K N, AU - Wishu,S, AU - Koteshwara,M, AU - Kumar,S Suresh, PY - 2004/10/15/received PY - 2004/11/16/accepted PY - 2005/1/25/pubmed PY - 2005/6/1/medline PY - 2005/1/25/entrez SP - 209 EP - 14 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 816 IS - 1-2 N2 - A simple, sensitive and selective HPLC method with UV detection (284 nm) was developed and validated for quantitation of rabeprazole in human plasma, the newest addition to the group of proton-pump inhibitors. Following solid-phase extraction using Waters Oasistrade mark SPE cartridges, the analyte and internal standard (Pantoprazole) were separated using an isocratic mobile phase of 5 mM ammonium acetate buffer (pH adjusted to 7.4 with sodium hydroxide solution)/acetonitrile/methanol (45/20/35, v/v) on reverse phase Waters symmetry C(18) column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 8%. A linear range of 20-1000 ng/mL was established. This HPLC method was validated with between- and within-batch precision of 2.4-7.2% and 2.2-7.3%, respectively. The between- and within-batch bias was -1.7 to 2.6% and -2.6 to 2.1%, respectively. Frequently coadministered drugs did not interfere with the described methodology. Stability of rabeprazole in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 3 months storage in a freezer. This validated method is sensitive, simple and repeatable enough to be used in pharmacokinetic studies. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/15664352/High_performance_liquid_chromatography_method_for_the_quantification_of_rabeprazole_in_human_plasma_using_solid_phase_extraction_ DB - PRIME DP - Unbound Medicine ER -