Determination and clinical pharmacy application of quetiapine fumarate in human serum by RP-HPLC / 药学实践杂志

ABSTRACT

Objective To establish a method for the determination of quetiapine fumarate in human serum by RP‐HPLC and apply it into clinical .Methods Extracting with ethyl ether after serum‐drug was alkalized ,and then determined by RP‐HPLC .The determination was performed on Zorbax Eclipse XDB‐C18 column with mobile phase consisted of methanol‐water (70∶30 ,containing 0 .5% triethylamine and 0 .4% glacial acetic acid) at the flow rate of 0 .6 ml/min .The detection wave‐length was set at 254 nm ,and the column temperature was 35 ℃ .The method would be applied into analysis of clinical medica‐tion .Results Quetiapine fumarate and the impurities could be completely separated ,and the linear range of quetiapine fumar‐ate were 50‐1 000 ng/ml(r=0 .999 5) .The recovery of the method was 98 .2%‐100 .1% and the recovery of extracting was 75 .2%‐84 .6% .RSD of intra‐day was within 0 .8%‐3 .7% and RSD of inter‐day was within 1 .4%‐5 .1% .The limit of quantita‐tion for quetiapine fumarate was 2 .1 ng/ml .This method had been applied into clinical pharmacy and achieved a good effects . Conclusions The method is simple ,accurate ,reproducible ,and sensitive for determination of quetiapine fumarate in human se‐rum .It has important significance on instructing the rational use of clinical medicine and discovering the unreasonable drug combination .