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采用高效液相色谱-紫外法对替考拉宁进行定量分析及其在韩国重症患者临床应用中的研究

Quantification of Teicoplanin Using the HPLC-UV Method for Clinical Applications in Critically Ill Patients in Korea.

作者信息

Lee Jaeok, Chung Eun-Kyoung, Kang Sung-Wook, Lee Hwa-Jeong, Rhie Sandy-Jeong

机构信息

College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Korea.

Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02453, Korea.

出版信息

Pharmaceutics. 2021 Apr 17;13(4):572. doi: 10.3390/pharmaceutics13040572.

Abstract

A high-performance liquid chromatography-ultraviolet detector (HPLC-UV) method has been used to quantify teicoplanin concentrations in human plasma. However, the limited analytical accuracy of previously bioanalytical methods for teicoplanin has given rise to uncertainty due to the use of an external standard. In this study, an internal standard (IS), polymyxin B, was applied to devise a precise, accurate, and feasible HPLC-UV method. The deproteinized plasma sample containing teicoplanin and an IS of acetonitrile was chromatographed on a C18 column with an acidic mobile phase consisting of NaHPO buffer and acetonitrile (78:22, /) by isocratic elution and detection at 220 nm. The linearity was in the range 7.8-500 mg/L calculated by the ratio of the teicoplanin signal to the IS signal. This analytical method, validated by FDA guidelines with ICH Q2 (R1), was successfully applied to analyze the plasma samples of patients in the intensive care unit for treating serious resistant bacterial infectious diseases, such as those by methicillin-resistant and . The methods suggested the potential for use in routine clinical practice for therapeutic drug monitoring of teicoplanin, providing both improved accuracy and a wide range of linearity from lower than steady-state trough concentrations (10 mg/L) to much higher concentrations.

摘要

一种高效液相色谱 - 紫外检测器(HPLC - UV)方法已被用于定量人血浆中的替考拉宁浓度。然而,由于使用外标,先前用于替考拉宁的生物分析方法的有限分析准确性导致了不确定性。在本研究中,应用内标(IS)多粘菌素B来设计一种精确、准确且可行的HPLC - UV方法。将含有替考拉宁和内标的去蛋白血浆样品用乙腈进行处理,然后在C18柱上进行色谱分析,流动相为酸性,由NaHPO缓冲液和乙腈(78:22,v/v)组成,通过等度洗脱,并在220 nm处进行检测。通过替考拉宁信号与内标信号的比值计算,线性范围为7.8 - 500 mg/L。该分析方法按照FDA指南和ICH Q2(R1)进行了验证,已成功应用于分析重症监护病房中治疗严重耐药细菌感染性疾病(如耐甲氧西林金黄色葡萄球菌感染等)患者的血浆样本。这些方法表明了在替考拉宁治疗药物监测的常规临床实践中具有应用潜力,提供了更高的准确性以及从低于稳态谷浓度(10 mg/L)到更高浓度的宽线性范围。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4633/8072975/f3f0c0305567/pharmaceutics-13-00572-g001.jpg

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