Kishore P, Rajani Kumar V, Satyanarayana V, Krishna D R
Drug Metabolism and Clinical Pharmacokinetics Division, University College of Pharmaceutical Sciences, Kakatiya University, Hyderabad, India.
Pharmazie. 2003 Jun;58(6):378-80.
A HPLC method for the determination of valproic acid (VA) in human serum using diazepam as internal standard (I.S.) is described. The eluates were separated with a C18 250 x 4.6 mm internal diameter reversed phase column maintained at a temperature of 50 degrees C. A mobile phase consisting of acetonitrile and 0.05 M phosphate buffer (pH 3.0) 45:55 v/v was used at a flow rate of 1.2 ml/min. Wavelength was switched from 360 nm to 210 nm during valproic acid retention. The method was linear over a concentration range of 20 to 160 microg/ml for valproic acid. Recovery was greater than 94% over a concentration range of 20 to 120 microg/ml and the limit of quantitation was 1 microg/ml. The intra day and inter day relative standard deviation (R.S.D.) measured at 20, 60, 80 and 120 microg/ml ranged from 1.46 to 5.34% and 0.83 to 5.03% respectively. The method is simple, rapid, accurate and sensitive and it was used for Therapeutic Drug Monitoring (TDM) in Indian epileptic patient population. The results obtained with this method correlated well with clinical practice.
描述了一种以地西泮为内标物测定人血清中丙戊酸（VA）的高效液相色谱法。洗脱液通过内径为4.6 mm、长度为250 mm的C18反相柱进行分离，柱温保持在50℃。流动相由乙腈和0.05 M磷酸盐缓冲液（pH 3.0）按45:55 v/v组成，流速为1.2 ml/min。在丙戊酸保留期间，波长从360 nm切换至210 nm。该方法在丙戊酸浓度范围为20至160 μg/ml时呈线性。在浓度范围为20至120 μg/ml时回收率大于94%定量限为1 μg/ml。在20、60、80和120 μg/ml水平测定的日内和日间相对标准偏差（R.S.D.）分别为1.46%至5.34%和0.83%至5.03%。该方法简单、快速、准确且灵敏，用于印度癫痫患者群体的治疗药物监测（TDM）。用该方法获得的结果与临床实践相关性良好。
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