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Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies.
Biomed Chromatogr. 2007 Dec; 21(12):1240-4.BC

Abstract

A simple, reliable HPLC method with UV detection (295 nm) in rat plasma was developed and validated for quantification of tenatoprazole, a novel proton pump inhibitor, which is in clinical trials. Following a single-step liquid-liquid extraction, the analyte and internal standard were separated using an isocratic mobile phase on a reverse phase C(18) column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 10%. A linear dynamic range of 20-6000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 2.9-6.3 and 1.4-5.8%, respectively. The between-batch and within-batch accuracy was 95.1-104.1 and 92.4-101.0%, respectively. This validated method is simple and repeatable enough to be used in pharmacokinetic studies.

Authors+Show Affiliations

Nirogi R
Pharmacokinetics and Drug Metabolism, Discovery Research, Suven Life Sciences Ltd, Serene Chambers, Banjara Hills, Hyderabad, India. Ramakrishna_nirogi@yahoo.co.in
Kandikere V
No affiliation info available
Mudigonda K
No affiliation info available
Bhyrapuneni G
No affiliation info available

MeSH

2-PyridinylmethylsulfinylbenzimidazolesAnimalsChromatography, High Pressure LiquidImidazolesMaleOmeprazoleProton Pump InhibitorsPyridinesRatsRats, WistarReference ValuesReproducibility of ResultsSensitivity and SpecificitySpectrophotometry, UltravioletTime Factors

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

17590865

Citation

Nirogi, Ramakrishna, et al. "Quantification of Tenatoprazole in Rat Plasma By HPLC: Validation and Its Application to Pharmacokinetic Studies." Biomedical Chromatography : BMC, vol. 21, no. 12, 2007, pp. 1240-4.
Nirogi R, Kandikere V, Mudigonda K, et al. Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies. Biomed Chromatogr. 2007;21(12):1240-4.
Nirogi, R., Kandikere, V., Mudigonda, K., & Bhyrapuneni, G. (2007). Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies. Biomedical Chromatography : BMC, 21(12), 1240-4.
Nirogi R, et al. Quantification of Tenatoprazole in Rat Plasma By HPLC: Validation and Its Application to Pharmacokinetic Studies. Biomed Chromatogr. 2007;21(12):1240-4. PubMed PMID: 17590865.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies. AU - Nirogi,Ramakrishna, AU - Kandikere,Vishwottam, AU - Mudigonda,Koteshwara, AU - Bhyrapuneni,Gopinadh, PY - 2007/6/26/pubmed PY - 2008/3/15/medline PY - 2007/6/26/entrez SP - 1240 EP - 4 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 21 IS - 12 N2 - A simple, reliable HPLC method with UV detection (295 nm) in rat plasma was developed and validated for quantification of tenatoprazole, a novel proton pump inhibitor, which is in clinical trials. Following a single-step liquid-liquid extraction, the analyte and internal standard were separated using an isocratic mobile phase on a reverse phase C(18) column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 10%. A linear dynamic range of 20-6000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 2.9-6.3 and 1.4-5.8%, respectively. The between-batch and within-batch accuracy was 95.1-104.1 and 92.4-101.0%, respectively. This validated method is simple and repeatable enough to be used in pharmacokinetic studies. SN - 0269-3879 UR - https://www.unboundmedicine.com/medline/citation/17590865/Quantification_of_tenatoprazole_in_rat_plasma_by_HPLC:_validation_and_its_application_to_pharmacokinetic_studies_ L2 - https://doi.org/10.1002/bmc.875 DB - PRIME DP - Unbound Medicine ER -