Impurity profiling and in-process testing of drugs for injection by fast liquid chromatography

Abstract

Liquid chromatography (LC) is considered by many as a mature technique. Nonetheless, LC technology continues to evolve driven by the need for high-throughput and high-resolution analyses. Over the past several years, small particle size packing materials have been introduced by several column manufacturers to enable fast and efficient LC separations. Several examples of pharmaceutical analyses, including impurity profiling of taxanes and atracurium besylate, in-process testing of peptides in injectable dosage form, using sub-2 μm column technology are presented in this paper, demonstrating some of the capabilities and limitations of the technology.

Spectrofluorimetric determination of eptifibatide in human plasma and dosage form

“…Chen and colleagues discussed the effect of retaining the integrity of the intra‐loop structure on increasing the relative abundance of formation of immonium ion fragments to facilitate the analysis and quantitation of peptides containing intra‐chain disulfide bonds such as EPT in triple quadrupole MS . Rocheleau and colleagues reported impurity profiling of EPT using a sub‐2 μm stationary phase column and compared it with conventional LC columns . Enhancement of fluorescence emitted by functionalized ZnS nanocrystals by the addition of various EPT concentrations was found to be proportional to the added amounts of EPT and was utilized for its quantitation .…”