Development of a Practical HPLC Method for In-hospital Quantitation of Various Medicinal Drugs at Blood Levels

Morikawa, Go; Sorimachi, Miho; Tamura, Kazuki; Moriiwa, Yukiko; Shoji, Atsushi; Okazawa, Katsuko; Yanagida, Akio

doi:10.2116/bunsekikagaku.68.473

Cited by 6 publications

(9 citation statements)

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“…In advance of the present clinical study, our previous methods [ 11 ] for the quantification of serum levels of four different drugs (CBZ, PHT, LTG, or VRCZ) were slightly modified and optimized to the patient sera in our hospital. Specifically, all patient sera were passed through a syringe filter (0.45 μm) before SPE treatment, and centrifugation times of the SPE cartridge were re-adjusted for each step.…”

Section: Resultsmentioning

confidence: 99%

“…Given these circumstances, we previously developed a practical HPLC platform for the in-hospital quantification of serum levels of various drugs [ 11 ]. The platform consists of the simple solid-phase extraction (SPE) of a drug in serum using a disposable centrifugal cartridge, followed by rapid HPLC quantification of the drug in the SPE eluate using an easy-to-use reversed-phase (RP) HPLC-UV apparatus.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the clinical and quantitative performance of a practical HPLC-UV platform for in-hospital routine therapeutic drug monitoring of multiple drugs

Morikawa,

Fukami,

Moriiwa

et al. 2023

J Pharm Health Care Sci

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Background In-hospital therapeutic drug monitoring (TDM) requires a suitable quantification method for target drugs from the viewpoint of precision, throughput, and testing costs. We previously developed a practical HPLC-UV platform for quantification of serum levels of various drugs. In this report, the platform was effectively applied to the quantification of patient serum levels of five different drugs by clinical professionals in our hospital during their daily work. Methods The residual sera of patients receiving carbamazepine (CBZ), phenytoin (PHT), lamotrigine (LTG), vancomycin (VCM), or voriconazole (VRCZ) were used in the present clinical study. The quantification method for each drug consisted of rapid solid-phase extraction (SPE) of each drug in the patient serum, followed by optimized HPLC-UV analysis of the drug in the SPE eluate. Furthermore, patient serum levels of PHT, CBZ, and VCM were also measured by ligand-binding assay using a cobas® analyzer in our hospital, and those of LTG and VRCZ were measured by HPLC-MS/MS at an outsourced provider. Passing–Bablok regression analysis and Bland–Altman analysis were employed to analyze the agreement of drug levels in patient sera, which was separately quantified using two different methods—our HPLC-UV platform and the cobas analyzer, or HPLC-UV and HPLC-MS/MS. Results All analytical conditions of the present method using our HPLC-UV platform were well optimized for each target drug quantification in the patient’s serum, and the quantification method for each drug was fully validated for accuracy, precision and reproducibility. Furthermore, Passing–Bablok regression analysis and Bland–Altman analysis revealed that patient serum levels of PHT, CBZ, and VCM quantified by our HPLC-UV platform were closely correlated with those quantified by the cobas® analyzer, and the levels of LTG and VRCZ quantified by our HPLC-UV platform were also correlated with those quantified by HPLC-MS/MS. Conclusions Our HPLC-UV platform can be performed without requiring special analytical techniques. This platform is expected to be used for the measurement of blood levels of multiple drugs for in-hospital routine TDM.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of the clinical and quantitative performance of a practical HPLC-UV platform for in-hospital routine therapeutic drug monitoring of multiple drugs

Morikawa,

Fukami,

Moriiwa

et al. 2023

J Pharm Health Care Sci

Self Cite

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“…The standard filter method is originally recommended as the pretreatment in LM1010 [ 5 ], though sample volume of > 400 μL is necessary for the filtration to obtain samples of 150 μL. In some authorized medical equipment for TDM, concentrations are measured using samples of 200 μL.…”

Section: Main Textmentioning

confidence: 99%

“…LM1010 automatically runs after pretreatment of samples (about 30 min required for 5 samples) and needs the least personal skills. Although the development for the measurement methods were reported [ 5 ], the clinical performance for each drug has yet to be evaluated. The aim of this study was to compare the measured serum voriconazole concentrations by LM1010 using HPLC with those by outsourcing measurement using LC-MS/MS.…”

Section: Introductionmentioning

confidence: 99%

Clinical evaluation of an authorized medical equipment based on high performance liquid chromatography for measurement of serum voriconazole concentration

Oda

Uchino

Kurogi

et al. 2021

J Pharm Health Care Sci

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Background Therapeutic drug monitoring for voriconazole is recommended for its optimum pharmacotherapy. Although the feedback of the measurement result of serum voriconazole concentration by outsourcing needs a certain time (days within a 1 week), there was no medical equipment for the measurement available in clinical practice. Recently, a medical equipment based on high performance liquid chromatography, named LM1010, has been developed and authorized for clinical use. In this study, to validate the clinical performance of LM1010, we compared the measured serum voriconazole concentrations by LM1010 with those by outsourcing measurement using liquid chromatography-tandem mass spectrometry. Methods We conducted the observational study approved by the institutional review board of Kumamoto University Hospital (No. 1786). Residual serum samples harvested for therapeutic drug monitoring were separated. Measured concentrations by LM1010 by the standard filter method (needs serum volume of > 400 μL) or the dilute method (needs serum volume of 150 μL) were compared with those by outsourcing, respectively. Acceptable measurement error range of 0.72–1.33 was considered. There were 69 serum samples, where the 35 or 34 samples were employed for evaluation of the standard filter method or the dilute method, respectively. Results The measured concentration using the standard filter method/outsourcing was 2.22/2.10 μg/mL as the median, 1.57–3.40/1.53–3.62 as the interquartile range, < 0.2–10.76/< 0.2–11.46 μg/mL as the range, while those using the dilute method/outsourcing was 2.36/2.29 μg/mL as the median, 1.08–2.94/1.03–3.06 as the interquartile range, 0.24–10.00/< 0.2–10.85 μg/mL as the range. The regression line for the standard filter method or the dilute method were y = 0.935x + 0.154 or y = 0.933x + 0.162, respectively. The standard filter method or the dilute method showed 11.4% samples (4/35, 95%CI 3.2–26.7%) or 8.8% samples (3/34, 95%CI 1.9–23.7%) out of the acceptable measurement error range, respectively. Conclusion Measurement of serum voriconazole concentration by LM1010 can be acceptable in clinical TDM practice.

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“…In the 1980s and 1990s, high-performance liquid chromatography (HPLC) played a significant role in the analysis of drug concentrations in blood. However, with the spread of simple automated analyzers based on ligand-binding assays and the promotion of outsourcing to clinical laboratories, the number of medical institutions with HPLC capability has decreased [ 1 ]. In the area of clinical toxicology, precision analytical equipment was installed in emergency departments in 1998 with support from the Ministry of Health, Labor, and Welfare, but most of the equipment are systems for high-performance liquid or gas chromatography coupled with mass spectrometer detectors; not many facilities use HPLC with UV–visible detectors as their main equipment [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

Importance and Reality of TDM for Antibiotics Not Covered by Insurance in Japan

Ebihara

Hamada

Kato

et al. 2022

IJERPH

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Under the Japanese health insurance system, medicines undergoing therapeutic drug monitoring (TDM) can be billed for medical fees if they meet the specified requirements. In Japan, TDM of vancomycin, teicoplanin, aminoglycosides, and voriconazole, which are used for the treatment of infectious diseases, is common practice. This means the levels of antibiotics are measured in-house using chromatography or other methods. In some facilities, the blood and/or tissue concentrations of other non-TDM drugs are measured by HPLC and are applied to treatment, which is necessary for personalized medicine. This review describes personalized medicine based on the use of chromatography as a result of the current situation in Japan.

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Development of a Practical HPLC Method for In-hospital Quantitation of Various Medicinal Drugs at Blood Levels

Cited by 6 publications

References 0 publications

Evaluation of the clinical and quantitative performance of a practical HPLC-UV platform for in-hospital routine therapeutic drug monitoring of multiple drugs

Evaluation of the clinical and quantitative performance of a practical HPLC-UV platform for in-hospital routine therapeutic drug monitoring of multiple drugs

Clinical evaluation of an authorized medical equipment based on high performance liquid chromatography for measurement of serum voriconazole concentration

Importance and Reality of TDM for Antibiotics Not Covered by Insurance in Japan

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