Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Chirality. 2011 Apr;23(4):333-8. doi: 10.1002/chir.20923. Epub 2010 Nov 2.
Enantiomeric resolution of teratolol was achieved on a vancomycin macrocyclic antibiotic chiral stationary phase known as Chirobiotic V with UV detection set at 220 nm. The polar ionic mobile phase (PIM) consisted of methanol-glacial acetic acid-triethylamine (100:0.01:0.015, v/v/v) has been used at a flow rate of 0.8 ml min(-1) . The calibration curves in plasma were linear over the range of 5-500 ng ml(-1) for each enantiomer with detection limit of 2 ng ml(-1) . The proposed method was validated in compliance with the international conference on harmonization (ICH) guidelines. The developed method applied for the trace analyses of tertatolol enantiomers in plasma and for the pharmacokinetic study of tertatolol enantiomers in rat plasma. The assay proved to be suitable for therapeutic drug monitoring and chiral quality control for tertatolol formulations by HPLC.
手性固定相 Chirobiotic V 是一种万古霉素大环抗生素，对特他洛尔实现了对映体拆分，检测波长为 220nm。极性离子流动相（PIM）由甲醇-冰醋酸-三乙胺（100:0.01:0.015，v/v/v）组成，流速为 0.8ml/min。每个对映体在血浆中的校准曲线在 5-500ng/ml 范围内呈线性，检测限为 2ng/ml。该方法符合国际协调会议（ICH）指南的要求进行了验证。所建立的方法应用于特他洛尔对映体在血浆中的痕量分析和特他洛尔对映体在大鼠血浆中的药代动力学研究。该测定方法证明适用于 HPLC 对特他洛尔制剂的治疗药物监测和手性质量控制。
