Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies.
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.
Nirogi
Ramakrishna
R
Pharmacokinetics and Drug Metabolism, Discovery Research, Suven Life Sciences Ltd, Serene Chambers, Banjara Hills, Hyderabad, India. Ramakrishna_nirogi@yahoo.co.in
Kandikere
Vishwottam
V
Mudigonda
Koteshwara
K
Bhyrapuneni
Gopinadh
G
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000818:Animals; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D007093:Imidazoles / Q000097:blood* / Q000493:pharmacokinetics / Q000592:standards; D008297:Male; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000592:standards; D054328:Proton Pump Inhibitors / Q000097:blood* / Q000493:pharmacokinetics / Q000592:standards; D011725:Pyridines / Q000097:blood* / Q000493:pharmacokinetics / Q000592:standards; D051381:Rats; D017208:Rats, Wistar; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013997:Time Factors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D007093:Imidazoles; D054328:Proton Pump Inhibitors; D011725:Pyridines; D009853:Omeprazole; C119998:Tenatoprazole