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KMID : 0369820050350060431
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 6 p.431 ~ p.436
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Validation of an HPLC Method for Nadolol in Human Plasma and Evaluation of Its Pharmacokinetics after a Single-dose in Korean Volunteers
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강춘모/Kang CM
트란트룽/김경호/명자혜/황성주/김미영/구효정/Tran Quoc Trung/Kim KH/Myung JH/Hwang SJ/Kim MY/Kuh HJ
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Abstract
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A high-performance liquid chromatographic method was validated for quantitation of nadolol in human plasma. Nadolol and internal standard, pindolol, were extracted with tert-butyl methyl ether after addition of 10 M sodium hydroxide solution. The analytes were separated on a reverse phased C18 column using a mobile phase consisting of 0.05 M ammonium phosphate monobasic buffer, acetonitrile and methanol (81: 17:2 v/v/v) and detected using a fluorescence detector (excitation wavelength 230 nm, emission wavelength 294 nm). The method was specific and sensitive enough to detect as low as 3 ng/mL of nadolol in human plasma. Linear calibration range was 3-150 ng/mL with correlation coefficient greater than 0.999. The overall accuracy was in the range of 96.8 to 103% and precision C.V.(%) 7.30 to 12.2%. The recovery was approximately 100% and stability was confirmed during storage and sample preparation. The present HPLC method was successfully applied to study bioavailability after oral administration of 80 mg of nadolol in healthy Korean subjects. The mean AUCt was 1968±397ng?hr/mL and Cmax of 186±79.3ng/mL was reached at 3.5±0.76hr. The mean t1/2 of nadolol was 17.3±2.59hr.
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KEYWORD
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Nadolol, HPLC, Fluorescence, Validation, Pharmacokinetics
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