| Objectives:To develop three HPLC methods for the determination of itraconazole, lansoprazole and cefaclor in human plasma,respectively.Methods:Three reversed-phase HPLC methods with UV detection for the determination of itraconazole,lansoprazole and cefaclor in human plasma have been developed,respectively.The stable phase is the same,a Kromai C18（4.6 mm×250 mm, 5μm）columns.After a simple liquid-liquid extraction with 1,2 -dichloroethane,the detection of itraconazole was set at the wavelength of 263 nm.The mobile phase was consisted of acetonitrile-water（78:22,v/v）.Lansoprazole was extracted by liquid-liquid extraction with mixture of diethyl ether and dichloromethane.The mobile phase was consisted of methanol -water（70:45,v/v）.The detection was set at the wavelength of 284 nm.Cefaclor was prepared from plasma samples by protein priciptation.The mobile phase was consisted of methanol-potassium dihydrogen phosphate(0.02 mol·L-1)（30:80,v/v）.The detection was set at the wavelength of 264 nm.Results:The linear calibration curve of itraconazole was obtained in the concentration range of 30.0～2300.0 ng·mL-1.The intra- and inter-day precision （RSD）was less then 6.38%,and the accuracy was 101.0～103.4%.The main pharmacokinetic parameters after a single oral dose of two itraconazole preparations 200 mg to 18 healthy volunteers were as following:Tmax（89±0.32）,（3.94±0.24）h, Cmax（1601.12±151.03）,（1678.74±200.37）ng·mL-1,t1/2（16.50±1.80）,（16.43±1.35） h,AUC（0â†'72）（21194.89±2604.04）,（21795.72±2657.52）ng·mL-1·h-1,AUC（0â†'∞） （22418.87±2921.60）,（23060.62±2865.28）ng·mL-1·h-1,respectively.The linear calibration curve of lansoprazole was obtained in the concentration range of 4.0～800.0 ng·mL-1.The intra- and inter-day precision（RSD）was less then 3.94%,and the accuracy was 95.9～109.0%.The main pharmacokinetic parameters after a single oral dose of two lansoprazole preparations 30 mg to 18 healthy volunteers were as following:Tmax（3.11±0.32）,（3.11±0.32）h,Cmax（399.24±41.12）,（400.95±34.22） ng·mL-1,t1/2（4.03±0.40）,（3.91±0.28）h,AUC（0â†'24）（1596.65±179.90）,（1600.34±125.62）ng·mL-1·h-1,AUC（（0â†'∞））（1644.52±174.62）,（1643.91±128.16）ng·mL-1·h-1, respectively.The linear calibration curve of cefaclor was obtained in the concentration range of 0.32～20.0μg·mL-1.The intra- and inter-day precision（RSD）was less then 5.73%,and the accuracy was 98.7～106.4%.The main pharmacokinetic parameters after a single oral dose of two cefaclor preparations 500 mg to 18 healthy volunteers were as following:Tmax（0.86±0.13）,（0.85±0.13）h,Cmax（10.99±1.33）,（11.22±1.54）μg·mL-1,t1/2（1.25±0.12）,（1.27±0.11）h,AUC（0â†'6）（14.22±1.77）,（14.59±1.71）μg·mL-1·h-1,AUC（0â†'∞）（15.07±1.68）,（15.52±1.64）μg·mL-1·h-1,respectively.Conclusions:The three methods can be utilized for bioequivalence study of itraconazole,lansoprazole and cefaclor preparations,respectively,which provide the advantages of simplicity,speed and sensitivity. |
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