Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Martens‐Lobenhoffer, Jens; Böger, Corinna R.; Kielstein, Jan T.; Bode‐Böger, Stefanie M.

doi:10.1016/j.jchromb.2022.123510

Cited by 17 publications

(12 citation statements)

References 6 publications

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“…The method was validated according to ICH guidelines, it was linear between 10–10000 ng mL −1 and 2–2000 ng mL −1 for NTV and RTN, respectively, sensitive with LLOQ values of 10 ng mL −1 and 2 ng mL −1 for NTV and RTN, respectively, and selective since no interference was detected. 55…”

Section: Methodsmentioning

confidence: 99%

“…The method was validated according to ICH guidelines, it was linear between 10-10000 ng mL −1 and 2-2000 ng mL −1 for NTV and RTN, respectively, sensitive with LLOQ values of 10 ng mL −1 and 2 ng mL −1 for NTV and RTN, respectively, and selective since no interference was detected. 55 Tables 5 and 6 summarize the measurement conditions of the various analytical methods applied in the quantication of NTV and RTN in pharmaceutical dosage forms and biological matrices, respectively.…”

Section: Nirmatrelvir (Ntv) and Ritonavir (Rtn)mentioning

confidence: 99%

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Recent analytical methodologies for the determination of anti-covid-19 drug therapies in various matrices: a critical review

2023

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Section: Methodsmentioning

confidence: 99%

Section: Nirmatrelvir (Ntv) and Ritonavir (Rtn)mentioning

confidence: 99%

Recent analytical methodologies for the determination of anti-covid-19 drug therapies in various matrices: a critical review

2023

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“…The described TLC procedure was used to determine nirmatrelvir and ritonavir in the pharmaceutical dosage form, Table 4 . The obtained data were accepted and compared with the data obtained of the reported method 18 . Furthermore, the method was used for the determination of nirmatrelvir and ritonavir in the spiked human plasma as it provided a high degree of detection and allowed the determination of nirmatrelvir the mean plasma Cmax for ritonavir (0.84 µg/mL) and ritonavir, the mean plasma Cmax for ritonavir (2.21 µg/mL) 24 .…”

Section: Resultsmentioning

confidence: 99%

“…LC–MS/MS was previously developed for determination of nirmatrelvir and ritonavir in the human plasma sample 18 . To date, no analytical methods have been introduced for determination of the drugs under the study in the new FDA approved co-packaged dosage form.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous green TLC determination of nirmatrelvir and ritonavir in the pharmaceutical dosage form and spiked human plasma

Imam

Abdelazim

Batubara

et al. 2023

Sci Rep

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Quantitative analysis of pharmaceutical compounds up to Nano gram levels is highly recommended to introduce feasible and sensitive tool for determination of the compounds in the pharmaceutical and biological samples. Nirmatrelvir plus ritonavir was recently approved in the US, the UK and Europe as a new co-packaged dosage form for the treatment of COVID-19. The objective of this work was to develop a more sensitive TLC method based on using β-cyclodextrin as a chiral selector additive in the mobile phase for simultaneous determination of nirmatrelvir and ritonavir in pure form, pharmaceutical formulation and spiked human plasma. The analysis procedures were developed using TLC aluminum silica gel plates and methanol–water- 2% urea solution of β-cyclodextrin (40:10:.5, by volume) as a mobile phase with UV detection at 215 nm. The developed method was successfully applied over a linearity range of 10–50 ng/band for both nirmatrelvir and ritonavir. The method was validated for limits of detection and quantitation, accuracy, precision, specificity, system suitability, and robustness. Furthermore, the eco-friendliness of the proposed method was assessed using the analytical eco-scale and the green analytical procedure index. The described method exhibited compliance with green analytical chemistry principles based on common green metric values.

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“…Reviewing literature, LC–MS/MS was the only reported method for analyzing nirmatrelvir and ritonavir in human plasma 25 . To date, no analytical methods enabled determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged dosage form.…”

Section: Introductionmentioning

confidence: 99%

Adjusted green HPLC determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged pharmaceutical dosage using supported computational calculations

Imam

Batubara

Gamal

et al. 2023

Sci Rep

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The greening of analytical methods has gained interest in the quantitative analysis field to reduce environmental impact and improve safety health conditions for analysts. Nirmatrelvir plus ritonavir is a new FDA approved co-packaged medication developed for the treatment of COVID-19. The aim of this research was to develop green fitted HPLC method using pre experimental computational testing of different stationary phases as well as selecting mobile phase regarding to green analytical chemistry principles. Computational study was designed to test the physical interaction between nirmatrelvir and ritonavir and different columns (C8, C18, Cyano column). The study showed that the C18 column was better for simultaneous HPLC analysis of the cited drugs. Regarding to green point of view, mobile phase consisted of ethanol: water (80:20, v/v) provided an efficient chromatographic separation of nirmatrelvir and ritonavir within a short analytical run time, reasonable resolution and excellent sensitivity. Isocratic elution was performed on a selected C18 column and a green adjusted mobile phase at flow rate of 1 mL/min and UV detection at 215 nm. The chromatographic system allowed complete baseline separation with retention times of 4.9 min for nirmatrelvir and 6.8 min for ritonavir. The method succeeded to determine nirmatrelvir and ritonavir over the concentration range of 1.0–20.0 μg/mL in the pure form and in pharmaceutical dosage form. Greenness profiles of the applied HPLC method was assessed using analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The results revealed adherence of the described method to the green analytical chemistry principles. The authors hope to provide a promising challenge for achieving green goals through integrating computational tools and applying them with green assessment metrics.

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Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Cited by 17 publications

References 6 publications

Recent analytical methodologies for the determination of anti-covid-19 drug therapies in various matrices: a critical review

Recent analytical methodologies for the determination of anti-covid-19 drug therapies in various matrices: a critical review

Simultaneous green TLC determination of nirmatrelvir and ritonavir in the pharmaceutical dosage form and spiked human plasma

Adjusted green HPLC determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged pharmaceutical dosage using supported computational calculations

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