Quantification of letermovir in human serum using high-performance liquid chromatography with diode array detection

Isberner, Nora; Aghai, Fatemeh; Schirmer, Diana; Kraus, Sabrina; Grigoleit, Götz Ulrich; Klinker, Hartwig

doi:10.1016/j.jchromb.2020.122399

Cited by 6 publications

(12 citation statements)

References 11 publications

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“…The accuracy of all the QCs at different levels was within ±15%, and precision was ≤15%. Both the methods used in our study and in a previous study 14) conformed with the FDA guidelines for bioanalytical method validation, in terms of accuracy and precision. 15) Dilution linearity with human blank plasma was investigated at a ratio of 1 : 9.…”

Section: Selectivitymentioning

confidence: 74%

“…3) Furthermore, according to a study conducted by Isberner et al, the median trough concentration of letermovir after oral administration of 240 or 480 mg in patients including children was 2603 ng/mL (range 175-12281 ng/mL), and two samples were less than 100 ng/mL. 14) These results suggest that letermovir In this study, a lower ULOQ than that used in a previous study (5000 ng/mL) 14) was chosen to improve the accuracy of our calibration curve, while a dilution integrity of 10-fold was assessed in order to account for concentrations above 1000 ng/mL.…”

Section: Methods Validation Linearity and Calibration Curvementioning

confidence: 99%

“…The LLOQ determined in this assay (10 ng/mL) was lower than the LLOQ established in a previous study by Isberner et al (100 ng/mL). 14) Accuracy, Precision, and Dilution Linearity Table 2 summarizes the results of the intra-assay and interassay accuracy and precision. The accuracy of all the QCs at different levels was within ±15%, and precision was ≤15%.…”

Section: Selectivitymentioning

confidence: 99%

“…11) In light of these findings, further studies for assessing the pharmacokinetics (PK) and pharmacodynamics (PD) are required. However, although multiple clinical studies 3,10,11,13) mention the use of LC/MS methods for quantifying letermovir in human plasma, there is no information regarding the full method, including its validation in the available literature. More recently, a new method for the quantification of letermovir in human serum using HPLC combined with diode array detector has been published.…”

Section: Introductionmentioning

confidence: 99%

“…More recently, a new method for the quantification of letermovir in human serum using HPLC combined with diode array detector has been published. 14) However, to date, no LC/MS method has been described in human plasma. Thus, the main purpose of this work was to develop and validate an ultraperformance liquid chromatography (UPLC)/MS method for quantifying letermovir in human plasma, which is suitable for clinical studies as well as for therapeutic drug monitoring.…”

Section: Introductionmentioning

confidence: 99%

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Development and Full Validation of a Bioanalytical Method for Quantifying Letermovir in Human Plasma Using Ultra-Performance Liquid Chromatography Coupled with Mass Spectrometry

Belabbas

Yamada

Tsuchiya

et al. 2021

CHEMICAL & PHARMACEUTICAL BULLETIN

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With the aim of studying the pharmacokinetics of letermovir, which is a newly developed antiviral agent for human cytomegalovirus, a rapid and simple ultra-performance liquid chromatography coupled with mass spectrometry (UPLC/MS) method was developed and validated for the quantification of letermovir in human plasma. Separation was performed in reverse phase mode using an ACQUITY UPLC BEH C18 column (130 Å, 1.7 µm, 2.1 50 mm) at a flow rate of 0.3 mL/min, 10 mM ammonium acetate-0.1% formic acid solution as mobile phase A, and acetonitrile as mobile phase B with a gradient elution. The method was validated over a linear range of 10-1000 ng/mL with a coefficient of determination (R 2 ) >0.99 using weighted linear regression analysis. The intra-and inter-assay accuracy (nominal%) and precision (relative standard deviation%) were within 15 and ≤15%, respectively. The specificity, recovery, matrix effect, stability, and dilution integrity of this method were also within acceptable limits. This method could be useful in studying the pharmacokinetics and pharmacodynamics, as well as performing the therapeutic drug monitoring of letermovir.

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Section: Selectivitymentioning

confidence: 74%

Section: Methods Validation Linearity and Calibration Curvementioning

confidence: 99%

Section: Selectivitymentioning

confidence: 99%