Determination of montelukast sodium in human plasma by column-switching high-performance liquid chromatography with fluorescence detection
Ochiai, H.; Uchiyama, N.; Takano, T.; Hara, K.; Kamei, T.
Journal of Chromatography. B, Biomedical Sciences and Applications 713(2): 409-414
ISSN/ISBN: 1387-2273 PMID: 9746257 DOI: 10.1016/s0378-4347(98)00179-0
MK-0476 (montelukast sodium) is a potent and selective cysteinyl leukotriene receptor antagonist that is being investigated in the treatment of asthma. A simple and sensitive method for the determination of MK-0476 in human plasma was developed using column-switching high-performance liquid chromatography (HPLC) with fluorescence detection. A plasma sample was injected directly onto the HPLC system consisting of a pre-column (Capcell pak MF) and an analytical column (Capcell pak C18) which were connected with a six-port switching valve. The column eluate was monitored with a fluorescence detector (excitation at 350 nm; emission at 400 nm). The calibration curve was linear in a concentration range of 1-500 ng ml-1 for MK-0476 in human plasma. The intra-day coefficients of variation of all concentrations within the range was less than 9.2%, and the intra-day accuracy values were between 97.2 and 114.6%. This method was used to measure the plasma concentration of MK-0476 following oral administration of the drug in humans.