Determination of Pemetrexed Disodium in Human Plasma by HPLC and Its Application / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for the determination of pemetrexed disodium in human plasma. METHODS:The plasma sample was determined by HPLC after protein were precipitated with strong acid. The determination was performed on Xterra?RP 18 column with mobile phase consisted of acetonitrile-50 mmol/L sodium dihydrogen phosphate buffer solution(15∶85) at the flow rate of 1.2 ml/min. The detection wavelength was set at 225 nm. RESULTS:The linear range of pemetrexed disodium were 1.0-32.0 mg/L (r=0.999 9,n=5) with recoveries of 86.35%-87.25%. RSDs of inter-day and intra-day were lower than 4.21%(n=5). Minimum detection concentration of plasma was 0.05 mg/L. The patients with high plasma concentration easily suf-fered from arrest of bone marrow. The plasma concentration was(18.56±4.50)mg/L,which could induce ADR;when the plasma concentration was (14.05 ± 6.72) mg/L,no ADR was found. There was statistical significance after t-test (P<0.05). CONCLU-SIONSThe method is simple,quick,accurate,sensitive and suitable for the plasma concentration determination of pemetrexed di-sodium and human pharmacokinetics study.