Jhee Ok Hwa, Jeon Yong Cheol, Choi Ho Sun, Lee Min Ho, Om Ae Son, Lee Joo-Won, Hong Jung Wook, Kim Yong Seok, Kang Ju Chan, Lee Yun Sik, Shaw Leslie M, Kang Ju Seop
Department of Food and Nutrition, College of Human Ecology, Hanyang University, Seoul 133-791, Korea.
Clin Chim Acta. 2006 Apr;366(1-2):179-84. doi: 10.1016/j.cca.2005.09.029. Epub 2005 Dec 13.
Tiropramide is used as an antispasmodic agent. A sensitive, selective and simple gas chromatography coupled to mass spectrometry (GC/MS) was developed for quantification of tiropramide in human plasma using internal standard (ISD, (+/-) alpha-benzoylamino-4-[2-(dimethylamino) ethoxy]-N,N-dipropylbenzenepropanamide).
Tiropramide and ISD were extracted from plasma by solid-liquid extraction and analyzed on a HP-5MS column with mass selective detector.
The retention times of tiropramide and ISD were approximately 9.8 and 10.2 min, respectively. The calibration curve showed good linearity in the concentration range 5-500 ng/ml (r2=0.998) for tiropramide in human plasma and showed good precision with CVs between 0.24% and 7.69%, respectively. The method was showed good accuracy with all intra-day (n=5) and inter-day (n=5) mean concentrations within 87.9-114.1% from nominal. The recovery of tiropramide and ISD were about 75.1% and 71.0% on the average, respectively. This method was successfully applied for the bioequivalence test of 2 formulations of tiropramide in 18 healthy male volunteers who received a single 100 mg dose of each formulation.
替罗哌胺用作解痉剂。建立了一种灵敏、选择性好且简便的气相色谱-质谱联用（GC/MS）方法，用于测定人血浆中的替罗哌胺，采用内标（ISD，(±)α-苯甲酰氨基-4-[2-(二甲基氨基)乙氧基]-N,N-二丙基苯丙酰胺）。
通过固液萃取从血浆中提取替罗哌胺和内标，并在配有质量选择检测器的HP-5MS柱上进行分析。
替罗哌胺和内标的保留时间分别约为9.8分钟和10.2分钟。校准曲线显示人血浆中替罗哌胺在5 - 500 ng/ml浓度范围内具有良好的线性（r2 = 0.998），精密度良好，变异系数分别在0.24%和7.69%之间。该方法准确性良好，日内（n = 5）和日间（n = 5）所有平均浓度均在标称值的87.9% - 114.1%范围内。替罗哌胺和内标的回收率平均分别约为75.1%和71.0%。该方法成功应用于18名健康男性志愿者接受单剂量100 mg每种制剂的替罗哌胺两种制剂的生物等效性试验。
