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一种用于同时分析复方制剂中辛伐他汀和生育三烯酚的反相高效液相色谱法的开发与验证。

Development and validation of a reversed-phase HPLC method for the simultaneous analysis of simvastatin and tocotrienols in combined dosage forms.

作者信息

Ali Hazem, Nazzal Sami

机构信息

Department of Basic Pharmaceutical Sciences, College of Pharmacy, University of Louisiana at Monroe, Monroe, LA 71201, USA.

出版信息

J Pharm Biomed Anal. 2009 May 1;49(4):950-6. doi: 10.1016/j.jpba.2009.02.009. Epub 2009 Feb 20.

Abstract

A RP-HPLC method for the simultaneous analysis of tocotrienol isoforms (TRF) and simvastatin (SIM) in SIM-TRF nanoparticles (NPs) was developed. Analytes were monitored by UV detection at 238 and 295 nm for SIM and TRF, respectively, using a gradient methanol/water elution. Calibration curves for TRF and SIM were linear over concentration range of 20-80 microg/mL and 1-10 microg/mL with correlation coefficients 0.9990 and 0.9991, respectively. The recovery of TRF and SIM from the NPs was in the range from 97.35 to 102.19% and from 92.71 to 104.35%, respectively. This developed method was successfully employed in quantifying both drugs in NPs for future use in cancer therapy.

摘要

建立了一种反相高效液相色谱法(RP-HPLC),用于同时分析辛伐他汀-生育三烯酚纳米颗粒(NPs)中的生育三烯酚异构体(TRF)和辛伐他汀(SIM)。使用梯度甲醇/水洗脱,分别在238 nm和295 nm处通过紫外检测监测分析物,其中238 nm用于检测SIM,295 nm用于检测TRF。TRF和SIM的校准曲线在20-80 μg/mL和1-10 μg/mL的浓度范围内呈线性,相关系数分别为0.9990和0.9991。从NPs中回收TRF和SIM的范围分别为97.35%至102.19%和92.71%至104.35%。所开发的方法成功用于定量NPs中的两种药物,以供未来癌症治疗使用。

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