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서지반출
LC-MS Determination and Bioavailability Study of Imidapril Hydrochloride after the Oral Administration of Imidapril Tablets in Human Volunteers
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  • LC-MS Determination and Bioavailability Study of Imidapril Hydrochloride after the Oral Administration of Imidapril Tablets in Human Volunteers
  • LC-MS Determination and Bioavailability Study of Imidapril Hydrochloride after the Oral Administration of Imidapril Tablets in Human Volunteers
저자명
Yun. Ji Hye,Myung. Ja Hye,Kim. Hye Jin,Lee. Sibeum,Park. Jong-Sei,Kim. Won,Lee. Eun-Hee,Moon. Cheol Jin,Hwang. Sung-Joo
간행물명
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
권/호정보
2005년|28권 4호|pp.463-468 (6 pages)
발행정보
대한약학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The purpose of the present study was to develop a standard protocol for imidapril hydrochloride bioequivalence testing. For this reason, a specific LC-MS method was developed and validated for the determination of imidapril in human plasma. A solid-phase extraction cartridge, $Sep-pak^{R}$ C18, was used to extract imidapril and ramipril (an internal standard) from deproteinized plasma. The compounds were separated using a XTerra $MS^{R}$?C18 column ($3.5 {mu}m, 2.1 imes150 mm$) and $acetonitrile-0.1\%$ formic acid (67:33, v/v) adjusted to pH 2.4 by 2 mmol/L ammonium formic acid, as mobile phase at 0.3 mL/min. Imidapril was detected as m/z 406 at a retention time of ca. 2.3 min, and ramipril as m/z 417 at ca. 3.6 min. The described method showed acceptable specificity, linearity from 0.5 to 100 ng/mL, precision (expressed as a relative standard deviation of less than $15\%$), accuracy, and stability. The plasma concentration-versus-time curves of eight healthy male volunteers administered a single dose of imidapril (10 mg), gave an $AUC_{12hr}$ of imidapril of $121.48pm35.81 ng mL^{-1} h$, and $C_{max} and T_{max}$ values of $32.59pm9.76 ng/mL and 1.75pm0.27 h$. The developed method should be useful for the determination of imidapril in plasma with sufficient sensitivity and specificity in bioequivalence study.