Determination of Pseudoephedrine Hydrochloride in Human Plasma by LC-MS / 中国药房

ABSTRACT

OBJECTIVE:To determine the concentration of pseudoephedrine hydrochloride in human plasma by LC/MS. METHODS:The separation of sample was performed on Zorbax Eclipse XDB C18 with diphenhydramine used as the internal standard.The mobile phase was a mixture of methanol-water(10mmol?L-1 NH4Ac plus 0.1% acetic acid)(55∶45) with a flow rate of 0.2mL?min-1.The column temperature was set at 30℃.The atmospheric pressure chemical ionization-mass spectrometry(APCI-MS) were adopted with pseudoephedrine m/z =166.1 and diphenhydramine m/z =242.3.RESULTS:The linear concentration range for pseudoephedrine was 3.2～408.96ng?mL-1(r=0.999 0) with lowest detection limit at 3.2ng?mL-1.The average recovery was 98.21% with both the intra-day RSD and the inter-day RSD at less than 13%.The stability of pseudoephedrine was stable.CONCLUSION:The method is of high sensibility and accuracy,and it can be used for blood concentration monitoring pharmacokinetic study of pseudoephedrine.