White D, Varlashkin P, Rusch D N
Burroughs Wellcome Company, Analytical Development Laboratories, Greenville, NC 27835.
J Pharm Sci. 1992 Dec;81(12):1204-9. doi: 10.1002/jps.2600811216.
A densitometric thin-layer chromatographic method for the analysis of process impurities in leucovorin calcium was developed and validated. Using this method, folic acid, N10-formyldihydrofolic acid, p-aminobenzoic acid, and N-(4-aminobenzoyl)-L-glutamic acid were monitored with a limit of detection of approximately 0.1% each. Both absorbance and fluorescence densitometric evaluations were utilized; fluorescence evaluation selectively detected impurities that were not chromatographically resolved from leucovorin.
开发并验证了一种用于分析亚叶酸钙中工艺杂质的密度测定薄层色谱法。使用该方法，对叶酸、N10-甲酰二氢叶酸、对氨基苯甲酸和N-(4-氨基苯甲酰基)-L-谷氨酸进行监测，每种物质的检测限约为0.1%。同时采用了吸光度和荧光密度测定评估；荧光评估可选择性地检测出在色谱上未与亚叶酸分离的杂质。
