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 NaH2PO4 buffer and acetonitrile (78:22, v/v) 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 Staphylococcus aureus and Enterococcus faecalis. 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.
Original language | English |
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Article number | 572 |
Journal | Pharmaceutics |
Volume | 13 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2021 |
Bibliographical note
Funding Information:Funding: This work was supported by a National Research Foundation of Korea (NRF) grant funded by the Korea Government Ministry of Science and ICT (2020R1A2C1009224 (S.J.R.) and 2020R1A2B5B01002489 (H.J.L.)) and the Ministry of Education (2017R1D1A1B03033389 (S.J.R.)). This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (NRF-2020R1A6A1A03043528 (S.J.R.)). The first author was supported by a Research Professor-Grant 2020 of Ewha Womans University (J.L.).
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
Keywords
- Clinical application
- HPLC-UV
- Human plasma
- Internal standard
- Polymyxin B
- Teicoplanin