Development and validation of molnupiravir assessment in bulk powder and pharmaceutical formulation by the RP-HPLC-UV method

“…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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“…This involves the separation and quantification of the drug and its metabolites in biological matrices, such as plasma or urine. The analysis of drug-drug interactions is essential to evaluate the safety and efficacy of drugs and to determine the pharmacokinetic parameters of drugs [41]. In addition to the above applications, RP-HPLC is also used in the analysis of drug stability, bioavailability, and pharmacokinetics.…”

Section: Applications Of Rp-hplc In Pharmaceutical Analysismentioning

confidence: 99%

A Comprehensive Review on Analytical Method Development using RP-HPLC and Recent Advances in Pharmaceutical Applications

Kumar¹,

Kumar²,

Kumar³

et al. 2023

J. Res. Appl. Sci. Biotechnol.

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The analytical technique of choice for separating, identifying, and quantifying complex mixtures is high-performance liquid chromatography (HPLC). Reverse-phase liquid chromatography (RP-HPLC) is the preferred separation mode for high-performance liquid chromatography (HPLC) due to its adaptability and higher selectivity for hydrophobic compounds. This review article discusses the fundamentals of reversed-phase high-performance liquid chromatography (RP-HPLC). This covers the separation principle, various stationary and mobile phase types, and separation-affecting variables. This article highlights the need of developing and testing such methods in addition to outlining the advantages of using RP-HPLC in industries like pharmaceutical, food, and environmental analysis. As examples of more recent advancements in RP-HPLC, new stationary and mobile phases, RP-HPLC downsizing, and hyphenated methods are also discussed. This review article provides a comprehensive tool for designing, refining, and validating RP-HPLC processes.

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Development and validation of molnupiravir assessment in bulk powder and pharmaceutical formulation by the RP-HPLC-UV method

Abstract: An accurate, sensitive and selective RP-HPLC-UV method has been established for the estimation of Molnupiravir (MOL) in pure bulk powder and pharmaceutical formulation.

Cited by 20 publications

References 36 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

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

A Comprehensive Review on Analytical Method Development using RP-HPLC and Recent Advances in Pharmaceutical Applications

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