Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment
Abstract Intestinal coccidiosis is a significant parasitic disease affecting poultry, resulting in substantial economic losses for the industry. It compromises the nutrition absorption, leading to weight loss and elevated mortality rates. Furthermore, the stress caused by the infection can compromis...
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Nature Portfolio
2025-02-01
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| author | Michel Y. Fares Shimaa Ebrahim Abdel Aziz Israa Abdelghafar khalil Asmaa Othman El Demerdash Neven M. Habib |
| author_facet | Michel Y. Fares Shimaa Ebrahim Abdel Aziz Israa Abdelghafar khalil Asmaa Othman El Demerdash Neven M. Habib |
| author_sort | Michel Y. Fares |
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| description | Abstract Intestinal coccidiosis is a significant parasitic disease affecting poultry, resulting in substantial economic losses for the industry. It compromises the nutrition absorption, leading to weight loss and elevated mortality rates. Furthermore, the stress caused by the infection can compromise the immune system, making poultry more susceptible to secondary infections and reducing overall productivity. As a result, simple analytical techniques are critical for determining anticoccidial drugs. A new, sensitive, and environmentally friendly HPLC method was developed for determining amprolium (AMP), sulfaquinoxaline (SUL), diaveridine (DIV), and vitamin K3 (VIT K3) in their formulations for the first time. Stability tests were performed under diverse stress conditions to verify the safety and efficiency of the formulation throughout its designated shelf time. These investigations ascertain the influence of various environmental conditions on a drug’s chemical stability and physical characteristics. A Supelcosil C18 column was used as the stationary phase, and 0.05 M KH2PO4 and acetonitrile were mixed in a ratio of 80:20 (v/v) as the developing system with a flow rate of 2.0 mL min−1. The proposed drugs were quantified at 260 nm. It was tested and found that the novel analytical method was linear for AMP and SUL between 20.0 and 60.0 µg mL−1, 2.0–6.0 µg mL−1 for VIT K3, and 2.1–6.3 µg mL−1 for DIV. The anticipated method was validated according to ICH guidelines. Advanced evaluation tools, such as GAPI, Red Green Blue (RGB 12, whiteness), Blue Applicability Grade Index (BAGI), the Analytical Eco-Scale, and (AGREE) assessed the sustainability profile of the proposed method, illustrating its enhanced environmental friendliness and sustainability. |
| format | Article |
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| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-2e8ac51abcdb4019890e47290ce81fba2025-08-20T04:02:46ZengNature PortfolioScientific Reports2045-23222025-02-0115111610.1038/s41598-024-84849-4Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessmentMichel Y. Fares0Shimaa Ebrahim Abdel Aziz1Israa Abdelghafar khalil2Asmaa Othman El Demerdash3Neven M. Habib4Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University in Beni-Suef (NUB)Department of Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar UniversityDepartment of Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar UniversityDepartment of Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar UniversityDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef UniversityAbstract Intestinal coccidiosis is a significant parasitic disease affecting poultry, resulting in substantial economic losses for the industry. It compromises the nutrition absorption, leading to weight loss and elevated mortality rates. Furthermore, the stress caused by the infection can compromise the immune system, making poultry more susceptible to secondary infections and reducing overall productivity. As a result, simple analytical techniques are critical for determining anticoccidial drugs. A new, sensitive, and environmentally friendly HPLC method was developed for determining amprolium (AMP), sulfaquinoxaline (SUL), diaveridine (DIV), and vitamin K3 (VIT K3) in their formulations for the first time. Stability tests were performed under diverse stress conditions to verify the safety and efficiency of the formulation throughout its designated shelf time. These investigations ascertain the influence of various environmental conditions on a drug’s chemical stability and physical characteristics. A Supelcosil C18 column was used as the stationary phase, and 0.05 M KH2PO4 and acetonitrile were mixed in a ratio of 80:20 (v/v) as the developing system with a flow rate of 2.0 mL min−1. The proposed drugs were quantified at 260 nm. It was tested and found that the novel analytical method was linear for AMP and SUL between 20.0 and 60.0 µg mL−1, 2.0–6.0 µg mL−1 for VIT K3, and 2.1–6.3 µg mL−1 for DIV. The anticipated method was validated according to ICH guidelines. Advanced evaluation tools, such as GAPI, Red Green Blue (RGB 12, whiteness), Blue Applicability Grade Index (BAGI), the Analytical Eco-Scale, and (AGREE) assessed the sustainability profile of the proposed method, illustrating its enhanced environmental friendliness and sustainability.https://doi.org/10.1038/s41598-024-84849-4AmproliumSulfaquinoxalineDiaveridineVitamin K3HPLCGreenness assessment |
| spellingShingle | Michel Y. Fares Shimaa Ebrahim Abdel Aziz Israa Abdelghafar khalil Asmaa Othman El Demerdash Neven M. Habib Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment Scientific Reports Amprolium Sulfaquinoxaline Diaveridine Vitamin K3 HPLC Greenness assessment |
| title | Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment |
| title_full | Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment |
| title_fullStr | Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment |
| title_full_unstemmed | Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment |
| title_short | Development and validation of a stability-indicating HPLC method for the simultaneous determination of anticoccidial drugs in veterinary formulations: greenness and whiteness assessment |
| title_sort | development and validation of a stability indicating hplc method for the simultaneous determination of anticoccidial drugs in veterinary formulations greenness and whiteness assessment |
| topic | Amprolium Sulfaquinoxaline Diaveridine Vitamin K3 HPLC Greenness assessment |
| url | https://doi.org/10.1038/s41598-024-84849-4 |
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