Sharma S C, Evans M B, Evans S J
Chauvin Pharmaceuticals, Romford, Essex, UK.
J Pharm Biomed Anal. 1995 Feb;13(2):129-37. doi: 10.1016/0731-7085(94)00141-n.
A high-performance liquid chromatographic (HPLC) method is described for direct separation of the enantiomers of metipranolol and its principal degradation product and main metabolite, desacetylmetipranolol. Separations are performed on a chiral stationary phase of cellulose tris-3,5-dimethylphenyl carbamate (Chiralcel OD), with hexane-propan-2-ol-diethylamine elution and UV detection at 278 nm. The method affords identification and determination of the optical purity of the bulk drug and its formulated ophthalmic products.
描述了一种高效液相色谱(HPLC)方法,用于直接分离美替洛尔及其主要降解产物和主要代谢物去乙酰美替洛尔的对映体。在纤维素三(3,5-二甲基苯基)氨基甲酸酯(手性拆分柱Chiralcel OD)手性固定相上进行分离,以正己烷-异丙醇-二乙胺洗脱,并在278nm处进行紫外检测。该方法可用于原料药及其眼科制剂的光学纯度的鉴定和测定。