Khan Muzaffar, Viswanathan Balaji, Rao D Sreenivas, Reddy G Sreenivas
Department of Analytical Research, Dr. Reddy's Laboratories Ltd., Discovery Research, Bollaram Road, Miyapur, Hyderabad 500 050, Andhra Pradesh, India.
J Pharm Biomed Anal. 2006 Jun 16;41(4):1447-52. doi: 10.1016/j.jpba.2006.03.018. Epub 2006 May 2.
A cyclodextrin modified capillary zone electrophoretic method has been developed for the evaluation of chiral purity of Frovatriptan using sulfobutyl ether beta cyclodextrin (SB-beta-CD) as the chiral selector. The method is highly specific, accurate and reproducible. The method was optimized with a systematic method development approach by optimizing the pH of electrolyte, attempting the separation in different classes of chiral selectors and modifying parameters such as cyclodextrin concentration and the organic modifier type and concentration. The optimized method was validated for specificity, precision, linearity, accuracy and stability in solution using Imidazole as the internal standard. The limit of detection (LOD) and limit of quantification (LOQ) were 1.0 microg/mL and 5.0 microg/mL respectively for each isomer. The method was applied for estimating the chiral purity of various batches of Frovatriptan.
已开发出一种环糊精修饰的毛细管区带电泳方法，以磺丁基醚β-环糊精（SB-β-CD）作为手性选择剂来评估夫罗曲普坦的手性纯度。该方法具有高度特异性、准确性和可重复性。通过系统的方法开发途径对该方法进行了优化，包括优化电解质的pH值，尝试在不同种类的手性选择剂中进行分离，并修改诸如环糊精浓度、有机改性剂类型和浓度等参数。使用咪唑作为内标，对优化后的方法进行了特异性、精密度、线性、准确性和溶液稳定性的验证。每种异构体的检测限（LOD）和定量限（LOQ）分别为1.0微克/毫升和5.0微克/毫升。该方法用于估算不同批次夫罗曲普坦的手性纯度。
