Analysis of rosuvastatin stress degradation behavior using liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry

Khedr, Alaa; Belal, F.; Ibrahim, F.; Elawady, Tarek

doi:10.1039/c3ay41210e

Cited by 5 publications

(4 citation statements)

References 22 publications

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“…The products were characterized as polycyclic isomers of the drug because the formation of polycyclic benzoquinazoline isomers was previously reported. In the same study a degradation product having m/z of 498 was also formed by photodegradation, the authors suggested it to be rosuvastatin-N-oxide [1]. Although the product of m/z 498 was found in our research (products C.1/C.2), the MS/MS pattern did not match the named molecule.…”

Section: Characterization Of Degradation Productscontrasting

confidence: 55%

“…Herein we propose that the product E is formed in the radical intramolecular cyclization (Scheme 4). The process is initiated by an attack of a hydroxyl radical which abstracts hydrogen atom attached to α carbon atom of the RSV heptanoic acid side chain (Scheme 4 (1)). This leads to the formation of a resonance stabilized intermediate (Scheme 4 (2)).…”

Section: Characterization Of Degradation Productsmentioning

confidence: 99%

“…Rosuvastatin (RSV), chemically described as (E)-7-(4-(4-fluorophenyl)-6-isopropyl-2 -(N-methylmethylsulfonamide)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid, is a member of the class of statins [1]. Statins are effective cholesterol-lowering drugs, most commonly prescribed in the treatment of hyperlipidemia, mixed dyslipidemia, and related conditions [2].…”

Section: Introductionmentioning

confidence: 99%

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NanoUPLC-QTOF-MS/MS Determination of Major Rosuvastatin Degradation Products Generated by Gamma Radiation in Aqueous Solution

et al. 2021

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Rosuvastatin, a member of the statin family of drugs, is used to regulate high cholesterol levels in the human body. Moreover, rosuvastatin and other statins demonstrate a protective role against free radical-induced oxidative stress. Our research aimed to investigate the end-products of free radical-induced degradation of rosuvastatin. To induce the radical degradation, an aqueous solution of rosuvastatin was irradiated using different doses of gamma radiation (50–1000 Gy) under oxidative conditions. Rosuvastatin and related degradation products were separated on nanoC18 column under gradient elution, and identification was carried out on hyphenated nanoUPLC and nanoESI-QTOF mass spectrometer system. Elemental composition analysis using highly accurate mass measurements together with isotope fitting algorithm identified nine major degradation products. This is the first study of gamma radiation-induced degradation of rosuvastatin, where chemical structures, MS/MS fragmentation pathways and formation mechanisms of the resulting degradation products are detailly described. The presented results contribute to the understanding of the degradation pathway of rosuvastatin and possibly other statins under gamma radiation conditions.

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Section: Characterization Of Degradation Productscontrasting

confidence: 55%

Section: Characterization Of Degradation Productsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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NanoUPLC-QTOF-MS/MS Determination of Major Rosuvastatin Degradation Products Generated by Gamma Radiation in Aqueous Solution

et al. 2021

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“…Also, this work has various merits, such as less consumption of solvent and less time for separation of components. Reference 23 shows the drug was highly unstable under acidic and photolysis under UV light. It is slightly sensitive to oxidation and heat.…”

Section: Fig 3: Forced Degradation Study Of Drug Substance and Drug P...mentioning

confidence: 99%

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2023

IJPSR

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Rosuvastatin is a widely used lipid-lowering medication that belongs to the class of "Statins" whereas Teneligiptin is a novel potent drug that belongs to the class of "DPP-4 inhibitors" which is used for the treatment of Type 2 Diabetes mellitus. The FDA recently approved the combination of these two drugs in 2021 since it proved to be highly effective for treating dyslipidemia associated with Type 2 Diabetes mellitus. Forced degradation studies have been performed on Rosuvastatin and Teneligliptin separately using various analytical techniques such as RP-HPLC, UV, RP-UFLC, RP-UPLC, UHPLC, HPTLC and TLC. Characterization of the degradation products generated during various stress conditions is also performed using various sophisticated techniques such as UPLC, LC/MS/MS, NMR, and FT-IR. These degradants can cause many adverse effects, such as carcinogenicity, mutagenicity, neurotoxicity, hepatotoxicity, skin sensitization, respiratory sensitization, etc. So, identifying and characterizing these degradation products will be very useful for their metabolic studies and in-silico toxicity assessment. In-silico toxicity studies are very helpful in predicting the toxic potential of these degradants, and it is performed using various software such as TOPKAT, Osiris, and DEREK. Thus, the present review aims to summarise the forced degradation studies as well as characterization of the degradation products generated from both rosuvastatin and teneligliptin using various modern analytical techniques so that it will significantly contribute in the future regarding their metabolic studies, determination of impurities during their bulk synthesis as well as toxicity predictions.INTRODUCTION: Degradation can be defined as the incapability of a particular substance to remain within its particular physical, chemical, microbiological, toxicological, and therapeutic specifications. "Forced degradation can be defined as the degradation of a New drug substance or new drug product at conditions more severe than the accelerated conditions.

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Stability-indicating RP-HPLC assay of three novel oral anticoagulants binary mixtures with rosuvastatin calcium: Application to pharmaceutical preparations and human plasma

Hamdy

Korany

Ebied

et al. 2022

Journal of Chromatography B

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Analysis of rosuvastatin stress degradation behavior using liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry

Cited by 5 publications

References 22 publications

NanoUPLC-QTOF-MS/MS Determination of Major Rosuvastatin Degradation Products Generated by Gamma Radiation in Aqueous Solution

NanoUPLC-QTOF-MS/MS Determination of Major Rosuvastatin Degradation Products Generated by Gamma Radiation in Aqueous Solution

Untitled

Stability-indicating RP-HPLC assay of three novel oral anticoagulants binary mixtures with rosuvastatin calcium: Application to pharmaceutical preparations and human plasma

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