Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology

Benzyl Nicotine (BN) and etofenamate (ETO), when combined with methylparaben (MP) or benzyl alcohol (BA), are highly effective for treating muscle and joint pain. This study presents a newly developed and verified RP-HPLC method for measuring ETO and BN in the presence of MP or BA in their dosage fo...

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Main Authors: Maha A. Alwaili, Osama A. Mahmoud, Samar M. Mahgoub, Manal A. Almalki, Hassan A. Rudayni, Ahmed A. Allam, Mustafa Ahmed Abdel-Reheim, Osama A. Mohammed, Mahmoud A. Mohamed
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Green Chemistry Letters and Reviews
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Online Access:https://www.tandfonline.com/doi/10.1080/17518253.2025.2452612
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author Maha A. Alwaili
Osama A. Mahmoud
Samar M. Mahgoub
Manal A. Almalki
Hassan A. Rudayni
Ahmed A. Allam
Mustafa Ahmed Abdel-Reheim
Osama A. Mohammed
Mahmoud A. Mohamed
author_facet Maha A. Alwaili
Osama A. Mahmoud
Samar M. Mahgoub
Manal A. Almalki
Hassan A. Rudayni
Ahmed A. Allam
Mustafa Ahmed Abdel-Reheim
Osama A. Mohammed
Mahmoud A. Mohamed
author_sort Maha A. Alwaili
collection DOAJ
description Benzyl Nicotine (BN) and etofenamate (ETO), when combined with methylparaben (MP) or benzyl alcohol (BA), are highly effective for treating muscle and joint pain. This study presents a newly developed and verified RP-HPLC method for measuring ETO and BN in the presence of MP or BA in their dosage forms. The approach utilizes eight environmentally friendly tools and the BAGI white tool to assess their eco-friendliness and effectiveness. The method uses a photodiode array PDA detector at 254 nm and symmetry column (C18, 150 mm × 4.6 mm, 5μm) in an isocratic process with a mobile phase of 0.1% orthophosphoric acid and methanol in a (45:55, v/v) adjusted pH 6.5 with 0.2% triethylamine solution at a flow rate of 1.5 mL/min, separation was accomplished in RP-HPLC. The calibration curves exhibited linearity across the concentration levels specified in the approach. Therefore, the procedure has been effectively applied in laboratory evaluation for medications in the presence of MP or BA, showcasing the exceptional selectivity of this strategy. The recommended approach was executed using the Six Sigma methodology, resulting in a Cpk value greater than 1.33. The procedures were successfully validated based on the ICH standards.
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institution Kabale University
issn 1751-8253
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publishDate 2025-12-01
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series Green Chemistry Letters and Reviews
spelling doaj-art-b2139750912344f89f5bc4ac870765022025-01-20T09:56:42ZengTaylor & Francis GroupGreen Chemistry Letters and Reviews1751-82531751-71922025-12-0118110.1080/17518253.2025.2452612Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodologyMaha A. Alwaili0Osama A. Mahmoud1Samar M. Mahgoub2Manal A. Almalki3Hassan A. Rudayni4Ahmed A. Allam5Mustafa Ahmed Abdel-Reheim6Osama A. Mohammed7Mahmoud A. Mohamed8Department of Biology, College of Science, Princess Nourah bint Abdulrahman University, Riyadh, Saudi ArabiaQC Supervisor at Penta Pharma Egypt, Ismailia, EgyptMaterials Science and Nanotechnology Department, Faculty of Postgraduate Studies for Advanced Science (PSAS), Beni-Suef University, Beni-Suef, EgyptChemistry Department, College of Science, Taibah University, Al-Madina, Saudi ArabiaDepartment of Biology, College of Science, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi ArabiaDepartment of Biology, College of Science, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi ArabiaDepartment of Pharmacology, College of Pharmacy, Shaqra University, Shaqra, Saudi ArabiaDepartment of Pharmacology, College of Medicine, University of Bisha, Bisha, Saudi ArabiaHikma Pharmaceutical Company, Beni-Suef, EgyptBenzyl Nicotine (BN) and etofenamate (ETO), when combined with methylparaben (MP) or benzyl alcohol (BA), are highly effective for treating muscle and joint pain. This study presents a newly developed and verified RP-HPLC method for measuring ETO and BN in the presence of MP or BA in their dosage forms. The approach utilizes eight environmentally friendly tools and the BAGI white tool to assess their eco-friendliness and effectiveness. The method uses a photodiode array PDA detector at 254 nm and symmetry column (C18, 150 mm × 4.6 mm, 5μm) in an isocratic process with a mobile phase of 0.1% orthophosphoric acid and methanol in a (45:55, v/v) adjusted pH 6.5 with 0.2% triethylamine solution at a flow rate of 1.5 mL/min, separation was accomplished in RP-HPLC. The calibration curves exhibited linearity across the concentration levels specified in the approach. Therefore, the procedure has been effectively applied in laboratory evaluation for medications in the presence of MP or BA, showcasing the exceptional selectivity of this strategy. The recommended approach was executed using the Six Sigma methodology, resulting in a Cpk value greater than 1.33. The procedures were successfully validated based on the ICH standards.https://www.tandfonline.com/doi/10.1080/17518253.2025.2452612Benzyl NicotineEtofenamateBenzyl alcoholMethylparabenEnvironmental Impact
spellingShingle Maha A. Alwaili
Osama A. Mahmoud
Samar M. Mahgoub
Manal A. Almalki
Hassan A. Rudayni
Ahmed A. Allam
Mustafa Ahmed Abdel-Reheim
Osama A. Mohammed
Mahmoud A. Mohamed
Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
Green Chemistry Letters and Reviews
Benzyl Nicotine
Etofenamate
Benzyl alcohol
Methylparaben
Environmental Impact
title Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
title_full Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
title_fullStr Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
title_full_unstemmed Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
title_short Quantitative analysis of quaternary mixtures in topical creams using cutting-edge HPLC technique: environmental impact and sigma methodology
title_sort quantitative analysis of quaternary mixtures in topical creams using cutting edge hplc technique environmental impact and sigma methodology
topic Benzyl Nicotine
Etofenamate
Benzyl alcohol
Methylparaben
Environmental Impact
url https://www.tandfonline.com/doi/10.1080/17518253.2025.2452612
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