Green adherent spectrophotometric determination of molnupiravir based on computational calculations; application to a recently FDA-approved pharmaceutical dosage form

Abdelazim, Ahmed H.; Abourehab, Mohammed A.S.; Elhalim, Lobna Mohammed Abd; Almrasy, Ahmed A.; Ramzy, Sherif

doi:10.1016/j.saa.2022.121911

Cited by 41 publications

(18 citation statements)

References 46 publications

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“…According to the ICH guidelines the method was valid, accurate, precise and green with linearity range 1–12 μg mL −1 , % recovery was 99.820, % RSD was 0.623 and analytical eco-scale score was 79. 41…”

Section: Methodsmentioning

confidence: 99%

“…According to the ICH guidelines the method was valid, accurate, precise and green with linearity range 1-12 mg mL −1 , % recovery was 99.820, % RSD was 0.623 and analytical eco-scale score was 79. 41 Hasan et al have established a novel silver-nanoparticles spectrophotometric method for ecofriendly and cost-effective assay of MLP routinely in quality control and research laboratories and have successfully applied it in studying the dissolution rate of marketed preparations. This method was based on a redox reaction between MLP (reducing agent) and silver nitrate as an (oxidizing agent), both were heated in presence of polyvinylpyrrolidone (PVP) for stabilization and sodium hydroxide then the absorbance was measured at 416 nm.…”

Section: Molnupiravir (Mlp)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: Molnupiravir (Mlp)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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“…Green indicated a safe procedure while red represented non-eco-friendly operations. The green analytical procedure index pictogram had five main sections, including sample preparation parameters, solvent and reagent parameters, instrumentation parameters, and an extra quantification mark 26 , 27 . Green analytical procedure index pictogram symbol of the proposed TLC method was shown in Fig.…”

Section: Resultsmentioning

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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“…Analytical balance (Shimadzu), digital pH meter (systolic), Digital Balance (Shimadzu), SonicatorPCi (3.5L), and Borosil Calibrated glassware were employed during the analysis. [11][12][13][14][15][16]…”

Section: Methodsmentioning

confidence: 99%

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

Deshpande¹,

Shaikh²,

Sable³

et al. 2023

IJPQA

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Background: Molnupiravir was granted approval by the UKS medicines and health product regulatory agency on 04 November 2021 and on 23 December 2021, granted emergency use of authorization by FDA. Objective: Provide a technique for measuring Molnupiravir in active pharmaceutical ingredients and formulations. Method: The wavelength maximum was found to be 236 nm. ICH guidelines were followed. The forced degradation study in the form of acidic, alkali, thermal, photolytic, hydrolytic, and oxidative stress conditions was carried out for Molnupiravir. Results: The method was linear, as measured by a coeffi cient of correlation (R2) of 0.9991 in the 10 to 50 μg/mL range. The %RSD for precision, accuracy, limit of detection (LoD), limit of quantitation (LoQ), ruggedness, and robustness was within acceptable limits per ICH Q2 (R1). Conclusion: HPLC equipped with a UV detector is used to create and verify the proposed method. An acetonitrile mobile phase component of 20% was used, demonstrating the more cost-eff ective technique. The extensive data of mobile phase optimization gives a complete idea of fi nal chromatographic conditions, which can be further implemented for future analysis. Molnupiravir shows less than 4% degradation under diff erent stress conditions. The forced degradation data helps show stability, indicating the behavior of Molnupiravir.

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Green adherent spectrophotometric determination of molnupiravir based on computational calculations; application to a recently FDA-approved pharmaceutical dosage form

Cited by 41 publications

References 46 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

New Stability Indicating RP-HPLC Method for Estimation of the Drug Molnupiravir

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