An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties
The development of suitable stability-indicating research in pharmaceutical analysis has received a lot of attention lately. A stability-indicating RP-HPLC method was developed and validated to identify chamomile extract as levomenol in topical cream formulations using an approved reference material...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-07-01
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| Series: | Results in Chemistry |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2211715625003212 |
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| author | Jin-Kui Ma Ahmed S. Darwish Amer Al Ali Aaser M. Abdelazim Wageh Sobhy Darwish Xiang Li Xiao-Chen Huang |
| author_facet | Jin-Kui Ma Ahmed S. Darwish Amer Al Ali Aaser M. Abdelazim Wageh Sobhy Darwish Xiang Li Xiao-Chen Huang |
| author_sort | Jin-Kui Ma |
| collection | DOAJ |
| description | The development of suitable stability-indicating research in pharmaceutical analysis has received a lot of attention lately. A stability-indicating RP-HPLC method was developed and validated to identify chamomile extract as levomenol in topical cream formulations using an approved reference material. Levomenol was exposed to a variety of drastic conditions in accordance with the ICH standards. Levomenol and its degradants were separated using the gradient LC technique; levomenol was measured at 40 °C on a Hypersil C-18 column. The usage of this traditional and common column and mobile phase emphasizes the economical, low cost by avoiding specific rare analysis requirements. Acetonitrile and 0.005 M potassium dihydrogen phosphate buffer pH 2.6 are combined in different ratios to form the mobile phase at a flow rate of 1.2 mL/min. Levomenol was detected at 204 nm, and the detected values are ranging from 1.0 to 10.0 μg/mL. The total injection time was <30 min, suggesting that the LC analysis is suitable for routine medication quality control assessments. For the best separation, acetonitrile was required. To assess the sustainability impact, three different methods were used: the MoGAPI, the AES, and AGREE. The chromatographic process's environmental friendliness is demonstrated by the final AES measurement of 67.5, AGREE measurement of 0.62, MoGAPI measurement of 70 with five green sections, BAGI score of 75.0, and whiteness measurement of 97.9. Needless to say, the simultaneous process is robust, long-lasting, accurate, precise, and good for the environment. The advantages and whiteness of the proposed strategy were compared to those of the published one. Lastly, levomenol may be sufficiently evaluated for routine quality control in both its pure form and the topical cream dosage form that contains chamomile extract. Moreover, the uniqueness of the suggested technique is guaranteed owing to its whiteness score and simplicity regarding the utilized techniques against the published HPLC methods discussed below. |
| format | Article |
| id | doaj-art-95230b03cb1544bba955754f306a33bd |
| institution | Kabale University |
| issn | 2211-7156 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Results in Chemistry |
| spelling | doaj-art-95230b03cb1544bba955754f306a33bd2025-08-20T04:00:33ZengElsevierResults in Chemistry2211-71562025-07-011610233810.1016/j.rechem.2025.102338An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green propertiesJin-Kui Ma0Ahmed S. Darwish1Amer Al Ali2Aaser M. Abdelazim3Wageh Sobhy Darwish4Xiang Li5Xiao-Chen Huang6School of Food & Pharmaceutical Engineering, Zhaoqing University, Zhaoqing 526061, ChinaFaculty of Science, Zagazig University, Egypt; Egyptian International Pharmaceutical Industries (EIPICO) Company, 10th of Ramadan city, EgyptDepartment of Medical Laboratory Sciences, College of Applied Medical Sciences, University of Bisha, Bisha 67714, P.O. Box 255, Saudi ArabiaDepartment of Medical Laboratory Sciences, College of Applied Medical Sciences, University of Bisha, Bisha 67714, P.O. Box 255, Saudi ArabiaFood Hygiene, Safety and Technology Department, Faculty of Veterinary Medicine, Zagazig University, Zagazig, EgyptCollege of Environmental and Chemical Engineering, Zhaoqing University, Zhaoqing 526061, China; Laboratory of Quality & Safety Risk Assessment for Agro-products (Zhaoqing), Ministry of Agriculture and Rural Affairs, Zhaoqing 526061, China; Correspondance to: Prof. Xiang Li, College of Environmental and Chemical Engineering, Zhaoqing University, Zhaoqing 526061, Guangdong Province, China.School of Food & Pharmaceutical Engineering, Zhaoqing University, Zhaoqing 526061, China; Correspondance to: Dr. Xiao-Chen Huang, School of Food & Pharmaceutical Engineering, Zhaoqing University, Zhaoqing 526061, Guangdong Province, China.The development of suitable stability-indicating research in pharmaceutical analysis has received a lot of attention lately. A stability-indicating RP-HPLC method was developed and validated to identify chamomile extract as levomenol in topical cream formulations using an approved reference material. Levomenol was exposed to a variety of drastic conditions in accordance with the ICH standards. Levomenol and its degradants were separated using the gradient LC technique; levomenol was measured at 40 °C on a Hypersil C-18 column. The usage of this traditional and common column and mobile phase emphasizes the economical, low cost by avoiding specific rare analysis requirements. Acetonitrile and 0.005 M potassium dihydrogen phosphate buffer pH 2.6 are combined in different ratios to form the mobile phase at a flow rate of 1.2 mL/min. Levomenol was detected at 204 nm, and the detected values are ranging from 1.0 to 10.0 μg/mL. The total injection time was <30 min, suggesting that the LC analysis is suitable for routine medication quality control assessments. For the best separation, acetonitrile was required. To assess the sustainability impact, three different methods were used: the MoGAPI, the AES, and AGREE. The chromatographic process's environmental friendliness is demonstrated by the final AES measurement of 67.5, AGREE measurement of 0.62, MoGAPI measurement of 70 with five green sections, BAGI score of 75.0, and whiteness measurement of 97.9. Needless to say, the simultaneous process is robust, long-lasting, accurate, precise, and good for the environment. The advantages and whiteness of the proposed strategy were compared to those of the published one. Lastly, levomenol may be sufficiently evaluated for routine quality control in both its pure form and the topical cream dosage form that contains chamomile extract. Moreover, the uniqueness of the suggested technique is guaranteed owing to its whiteness score and simplicity regarding the utilized techniques against the published HPLC methods discussed below.http://www.sciencedirect.com/science/article/pii/S2211715625003212AGREEBAGIChamomile LevomenolMoGAPIRP-HPLCWhiteness |
| spellingShingle | Jin-Kui Ma Ahmed S. Darwish Amer Al Ali Aaser M. Abdelazim Wageh Sobhy Darwish Xiang Li Xiao-Chen Huang An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties Results in Chemistry AGREE BAGI Chamomile Levomenol MoGAPI RP-HPLC Whiteness |
| title | An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties |
| title_full | An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties |
| title_fullStr | An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties |
| title_full_unstemmed | An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties |
| title_short | An ecologically sound HPLC determination of LEVOMENOL in topical therapies using a certified reference material with green properties |
| title_sort | ecologically sound hplc determination of levomenol in topical therapies using a certified reference material with green properties |
| topic | AGREE BAGI Chamomile Levomenol MoGAPI RP-HPLC Whiteness |
| url | http://www.sciencedirect.com/science/article/pii/S2211715625003212 |
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