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- Original Article 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
- Yun Jung Yang, Soon Chul Myoung, Sae Chul Kim, Yeon Pyo Hong
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DOI: https://doi.org/10.35371/kjoem.2005.17.1.70
Published online: March 31, 2005
1Department of Preventive Medicine and Community Health, College of Medicine, Chung-Ang University, Korea. hyp026@cau.ac.kr 
2Department of Urology, Chung-Ang University Hospital, Korea.
2Department of Urology, Chung-Ang University Hospital, Korea.
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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.
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