在实际样品分析过程中通过液相色谱-串联质谱法观察到的氟伐他汀潜在新的等压代谢物。
Potentially new isobaric metabolite of fluvastatin observed by LC-MS/MS during incurred sample analysis.
作者信息
Taillon Marie-Pierre, Côté Cynthia, Furtado Milton, Garofolo Fabio
机构信息
Algorithme Pharma Inc., 575 Armand-Frappier Blvd., Laval (Montréal), Quebec, H7V 4B3, Canada.
出版信息
Bioanalysis. 2011 Aug;3(16):1827-35. doi: 10.4155/bio.11.186.
BACKGROUND
Fluvastatin (Lescol(®)) is a racemic mixture of two erythro stereoisomers and metabolizes into two threo stereoisomers. A method was developed to chromatographically separate fluvastatin from its threo isomers to support a bioequivalence study.
RESULTS
During incurred samples analysis, an additional peak sharing the same mass transition as fluvastatin was observed and interfered with fluvastatin's quantification. Consequently, the chromatographic conditions were modified in order to resolve fluvastatin and the interference. Extensive evaluations were performed to ensure that the interference is not a degradation product generated during sample processing.
CONCLUSION
An isobaric compound of fluvastatin was discovered, which required chromatographic separation from fluvastatin to obtain a reliable bioanalytical method. The investigation performed suggests that the interference is produced in vivo and is a possible metabolite of fluvastatin.
背景
氟伐他汀（来适可（®））是两种赤型立体异构体的外消旋混合物，可代谢为两种苏型立体异构体。开发了一种色谱法从其苏型异构体中分离氟伐他汀的方法，以支持生物等效性研究。
结果
在分析实际样品时，观察到一个与氟伐他汀具有相同质量转移的额外峰，干扰了氟伐他汀的定量。因此，对色谱条件进行了修改，以分离氟伐他汀和干扰物。进行了广泛的评估，以确保干扰物不是样品处理过程中产生的降解产物。
结论
发现了氟伐他汀的一种等压化合物，需要从氟伐他汀中进行色谱分离，以获得可靠的生物分析方法。所进行的研究表明，干扰物是在体内产生的，可能是氟伐他汀的一种代谢产物。
Zotero 插件