Validation of High Performance Liquid Chromatographic Method with UV Detector for the Determination of Di(2-ethylhexyl)Phthalate in Plasma in some Korean Male Workers.
- Author:
Yun Jung YANG
1
;
Soon Chul MYOUNG
;
Sae Chul KIM
;
Yeon Pyo HONG
Author Information
1. Department of Preventive Medicine and Community Health, College of Medicine, Chung-Ang University, Korea. hyp026@cau.ac.kr
- Publication Type:Original Article
- Keywords:
Di-(2-ethylhexyl)phthalate;
HPLC-UV;
CDER guideline;
Validity;
Plasma;
Korean male
- MeSH:
Calibration;
Diethylhexyl Phthalate;
Drug Evaluation;
Humans;
Limit of Detection;
Male*;
Plasma*
- From:Korean Journal of Occupational and Environmental Medicine
2005;17(1):70-78
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVES: This study was conducted to validate a simple, rapid and sensitive reverse-phase high-performance liquid chromatographic method with UV detector (HPLC-UV) and present the plasma level of di(2-ethylhexyl)phthalate (DEHP) in some Korean male workers. METHODS: HPLC-UV for quantification of plasma DEHP was validated by the following guideline from the Center for Drug Evaluation and Research (CDER)-calibration/standard curve, precision, accuracy and recovery. Plasma DEHP from 255 healthy Korean male workers aged from 30 to 60 years was analyzed by validated HPLC-UV method. RESULTS: The calibration curve over the range 0~150 microgram/liter for the plasma DEHP standard solution showed linearity(r2=0.999). The limit of detection (LOD) and limit of quantification (LOQ) of plasma DEHP were 5.22 microgram/liter and 15.81 microgram/liter, respectively. The accuracy and precision for 2.5 microgram/liter of DEHP were acceptable in CDER guideline on the second and third day but not first day, and those for 50 microgram/liter and 150 microgram/liter of DEHP were acceptable on all three days(Ed-confirm this addition). The distribution of plasma DEHP level was skewed to the left and ranged from 0 to 18.9 microgram/liter. The plasma DEHP level was lower than 10 microgram/liter for 98 % of subjects and lower than 5 microgram/liter for 85 %. The geometric mean and standard deviation of plasma DEHP were 0.4 +/- 1.5 microgram/liter. CONCLUSIONS: The HPLC-UV method for quantification of plasma DEHP was acceptable by CDER guideline. The plasma DEHP of 255 Korean male workers ranged from 0 to 18.9 microgram/liter and the distribution was skewed to the left.
