Abstract
This method is used for the determination of itraconazole in human plasma by liquid-liquid extraction and high performance liquid chromatography. Felodipine was used as an internal standard. After extraction of the plasma with diethyl ether, the centrifuged upper layer was then transferred. The supernantant was evaporated and then reconsituted with mobile phase. The mobile phase was composed of 10 mM ammonium acetate adjusted to pH 7 by phosphoric acid with a flow rate of 0.2 mL/min. A C18 reversed-phase column with a pre-column was used as the analytial column. Linear detection responses were obtained for itraconzole concentration range for 2~1,000 ng/mL. The correlation coefficient of linear regression($R^2$) was 0.9991, limit of quantification (LOQ) was 2 ng/mL, reproducibility was less than 10.8 %, and accuracy was 97.2~108.2%. This method has been successfully applied to the pharmacokinetic study of itraconazole in human plasma.
본 연구는 LLE(liquid-liquid extraction) 전처리 방법과 HPLC/UV를 이용하여 혈장에서 이트라코나졸을 정량 분석하는 방법을 연구하였다. 이트라코나졸과 내부표준물질(펠로디핀)을 디에틸에테르로 추출하고 C18 컬럼을 이용하여 분리한 후 UV 검출기를 통하여 254 nm에서 검출하였다. 이동상은 10 mM 아세트산 암모늄 완충액(pH 7) :아세토나이트릴(35:65, v/v) 혼합용액을 사용하였으며, 유속은 0.2 mL/min.으로 하였다. 정량범위는 2~1,000 ng/mL 이며, 상관관계($R^2$)는 0.9991로 좋은 직선성을 보였다. 정량한계는 2 ng/mL, 재현성은 변동계수가 10.8 이하, 정확도는 97.2~108.2% 였다. 이 분석방법은 혈장 중의 약물 정량 및 약물의 약동력학에 유용함을 보여주었다.
