Bolaji O O, Onyeji C O, Ogungbamila F O, Ogunbona F A, Ogunlana E O
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria.
J Chromatogr. 1993 Dec 8;622(1):93-7. doi: 10.1016/0378-4347(93)80254-2.
A simple and sensitive HPLC method for the determination of drotaverine in human plasma and urine has been developed. Alkalinized plasma or urine was extracted with organic solvent and the basic components in the organic phase were back-extracted into 0.1 M HCl. An aliquot of the aqueous layer was injected onto the column and the eluent was monitored at 254 nm. Separation was performed on a C18-column with 0.02 M sodium dihydrogen phosphate-methanol (30:70, v/v) containing perchlorate ion at pH 3.2 as mobile phase. Drotaverine was well resolved from the plasma constituents and internal standard. An excellent linearity was observed between peak-height ratios and plasma concentrations and the intra- and inter-assay coefficients of variation were always < 10%. The lowest limit of detection (signal-to-noise ratio 3:1) was 6 ng/ml. The method is suitable for therapeutic monitoring and pharmacokinetic studies of drotaverine in humans as well as in animal models.
已开发出一种简单且灵敏的高效液相色谱法，用于测定人血浆和尿液中的屈他维林。碱化后的血浆或尿液用有机溶剂萃取，有机相中的碱性成分再反萃取到0.1 M盐酸中。取一份水层注入色谱柱，在254 nm处监测洗脱液。在C18柱上进行分离，以pH 3.2的含高氯酸根离子的0.02 M磷酸二氢钠 - 甲醇（30:70，v/v）为流动相。屈他维林与血浆成分和内标物得到了很好的分离。峰高比与血浆浓度之间呈现出良好的线性关系，批内和批间变异系数始终<10%。最低检测限（信噪比3:1）为6 ng/ml。该方法适用于人体以及动物模型中屈他维林的治疗监测和药代动力学研究。
