모노리틱 칼럼을 이용한 혈장 중 펜시클로버의 HPLC 신속분석법 개발 및 이를 이용한 생물학적동등성시험

Abstract

A simple and rapid HPLC method with fluorescence detection(FLD) for quantitation of penciclovirin human plasma using a monolithic column was developed and validated. Penciclovir and ganciclovir(internalstandard, I.S.) were separated on a Chromolith column RP-18e (4.6×100 mm) with a mobile phase consisting(3/97, pH 2.5) and (B) methanol/50 mM sodium phosphate buffer containing 20 mg/L sodium dodecyl sulfate(50/50, pH 2.5) at a flow gradient of 1.6~4.0 mL/min. The retention times of penciclovir and internal standardwere less than 4.0 min. Calibration curve was linear (R2=0.9994) over a concentration range of 0.1~5 g/mL.. Corresponding authorPhone : +82-(0)2-820-5601, 5674 Fax : +82-(0)2-3280-5596E-mail: youmjr@cau.ac.kr324 .......................Analytical Science & TechnologyIntra-day precision, accuracy and inter-day precision were 1.36~8.55 %, 92.8~100.0 % and 0.93~5.62 %,respectively with a limit of quantitation at 0.1 g/mL. The present HPLC-FLD method is sensitive, preciseand accurate. The method described herein has been successfully used for the bioequivalence study of afamciclovir formulation product after oral administration to healthy Korean volunteers