Green Chromatographic Determination of Antihyperlipidemic in Their Binary Mixture, in Presence of Their Impurities and Degradation Products and Biological Fluids; Lean Six Sigma Application

Green Chromatographic Determination of Antihyperlipidemic in Their Binary Mixture, in Presence of Their Impurities and Degradation Products and Biological Fluids; Lean Six Sigma Application | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Green Chromatographic Determination of Antihyperlipidemic in Their Binary Mixture, in Presence of Their Impurities and Degradation Products and Biological Fluids; Lean Six Sigma Application May H. Abdelwahab, Samah S. Abbas This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8012943/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Sensitive and specific green stability-indicating methods were developed for simultaneous determination of antihyperlipidemic Fenofibrate and Rosuvastatin in the binary mixture in bulk powders, tablets, in the presence of their impurities and degradation products, and human plasma by the HPLC method. The first method was based on HPTLC separation of the cited drugs from their impurities and degradation products followed by spectrodensitometric measurement of the bands at 242 nm. The separation was carried out using hexane-isopropanol-triethylamine (12:11:0.1, by volume) as a developing system. The second method was based on reversed-phase robust HPLC separation of the cited drugs from their impurities and degradation products with a mobile phase consisting of a mixture of ethanol/0.03% SDS -0.02 M citrate buffer/0.03% SDS pH 3 with citric acid gradient elution. Quantitation was achieved with UV detection at 276 nm. For the HPTLC-spectrodensitometric method the calibration curves in the range of 0.5-32 µg band-1, 0.2-13 µg band-1, for Fenofibrate and Rosuvastatin, respectively, and the HPLC method in the range of 2-32 µg mL-1 and 0.2-16 µg mL-1, for Fenofibrate and Rosuvastatin, respectively. Also, validated by Six Sigma quality using the accuracy profile for HPLC separation method, where, response surface/tolerance analysis was used. Fenofibrate Rosuvastatin HPTLC-spectrodensitometric HPLC measurement Six sigma The accuracy profile Response surface Tolerance analysis Full Text Additional Declarations No competing interests reported. Scheme 1 to 3 are available in the Supplementary Files section. Table 1 to 12 are available in the Supplementary Files section. Supplementary Files sch1tiff.tiff Scheme 1: The proposed degradation pathway of Fenofibrate. sch2tiff.tiff Scheme 2: The proposed degradation pathway of Rosuvastatin acid-stress conditions. sch3tiff.tiff Scheme 3: The proposed degradation pathway of Rosuvastatin oxidative-stress conditions. Tables.doc Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8012943","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":539467216,"identity":"1c30a17f-e088-41ec-b71f-7e1d6e5be29a","order_by":0,"name":"May H. 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