High-performance liquid chromatography method for the quantification of pantoprazole in human plasma.
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.
Ramakrishna
N V S
NV
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Banjara Hills, Hyderabad 500034, India. nvsrk@suven.com
Vishwottam
K N
KN
Wishu
S
S
Koteshwara
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000097:blood; D000077402:Pantoprazole; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013454:Sulfoxides / Q000097:blood*; D014466:Ultraviolet Rays
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole