Validation of a new high-performance liquid chromatography assay for nizatidine.
An expedient high-performance liquid chromatography (HPLC) assay for nizatidine measurement in human plasma was developed and validated. After deproteinization of 200 microL of plasma by filtration, nizatidine and 4-amino-antipyrine (internal standard) were separated (capacity ratio 3.0 and 6.63, respectively) on Nova-Pak C18 cartridge at room temperature (RT), and detected spectrophotometrically at 320 nm. The mobile phase, 0.02 mol/L disodium hydrogen phosphate, acetonitrile, methanol, and triethylamine (80:10:10:0.05 vol/vol), was delivered at 1.5 mL/min. Calibration curves were linear (r2 > or = 0.999) in the range 0.02 to 5 microg/mL, detection and quantification limits were 0.01 and 0.02 microg/mL, respectively, intra-run and inter-run coefficients of variation were < or = 3.5% and < or = 4.2%, respectively, and recovery was >90%. Nizatidine was stable for at least 4 hours at RT, 12 weeks at -20 degrees C, and 3 freeze-thaw cycles in plasma; 16 hours at RT and 48 hours at -20 degrees C in deproteinized plasma; and 6 hours at RT and 3 weeks at -20 degrees C in water.
Yusuf
Ahmed
A
Center for Clinical Research, King Faisal Specialist Hospital & Research Center, Riyadh, Kingdom of Saudi Arabia.
Al Dgither
Saleh
S
Hammami
Muhammad M
MM
D000675:Ampyrone / Q000032:analysis; D000983:Antipyrine / Q000031:analogs & derivatives / Q000032:analysis; D002214:Capsules; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006635:Histamine H2 Antagonists / Q000032:analysis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016567:Nizatidine / Q000032:analysis* / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013997:Time Factors
D002214:Capsules; D006635:Histamine H2 Antagonists; D000675:Ampyrone; D016567:Nizatidine; D000983:Antipyrine