Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method
The combined therapy of diminazene aceturate (DMZ) and phenazone (PHENZ) is widely used in veterinary medicine to combat trypanosomiasis and babesiosis. This study presents a novel, validated HPLC method for accurately quantifying DMZ and PHENZ in various pharmaceutical formulations, including bulk...
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Institute for Researches and Community Services Universitas Muhammadiyah Palangkaraya
2024-11-01
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| Series: | Borneo Journal of Pharmacy |
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| Online Access: | https://journal.umpr.ac.id/index.php/bjop/article/view/3588 |
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| author | Amna Mubarak Shaza Wagiealla Shantier Magdi Awadalla Mohamed Elrasheed Ahmed Gadkariem |
| author_facet | Amna Mubarak Shaza Wagiealla Shantier Magdi Awadalla Mohamed Elrasheed Ahmed Gadkariem |
| author_sort | Amna Mubarak |
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The combined therapy of diminazene aceturate (DMZ) and phenazone (PHENZ) is widely used in veterinary medicine to combat trypanosomiasis and babesiosis. This study presents a novel, validated HPLC method for accurately quantifying DMZ and PHENZ in various pharmaceutical formulations, including bulk powders, sachets, vials, and injectables. The chromatographic separation was achieved using a C18 column (150 x 4.6 mm, 5 μm particle size) with a mobile phase composed of phosphate buffer (pH 3.0) and methanol (70:30 v/v) at a flow rate of 1 mL/minute. UV detection was set at 250 nm. The method demonstrated linearity over a concentration range of 20-100 μg/mL for DMZ and 25-125 μg/mL for PHENZ, with correlation coefficients exceeding 0.999. Forced degradation studies were conducted under various stress conditions to assess the method's stability-indicating power. DMZ exhibited first-order degradation under acidic pH conditions. While slight degradation (2.4-3.1%) was observed under alkaline, UV, and indoor room light conditions, PHENZ remained stable. The validated HPLC method effectively quantified DMZ and PHENZ in the presence of their degradation products and impurities, demonstrating its suitability for quality control and stability studies of these combined drug formulations.
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| format | Article |
| id | doaj-art-53976ed540a1401a861e93ec9e0a24ee |
| institution | Kabale University |
| issn | 2621-4814 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Institute for Researches and Community Services Universitas Muhammadiyah Palangkaraya |
| record_format | Article |
| series | Borneo Journal of Pharmacy |
| spelling | doaj-art-53976ed540a1401a861e93ec9e0a24ee2025-01-08T08:42:15ZengInstitute for Researches and Community Services Universitas Muhammadiyah PalangkarayaBorneo Journal of Pharmacy2621-48142024-11-017410.33084/bjop.v7i4.3588Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic MethodAmna Mubarak0Shaza Wagiealla Shantier1Magdi Awadalla Mohamed2Elrasheed Ahmed Gadkariem3University of KhartoumUniversity of KhartoumAl Jouf UniversityUniversity of Khartoum The combined therapy of diminazene aceturate (DMZ) and phenazone (PHENZ) is widely used in veterinary medicine to combat trypanosomiasis and babesiosis. This study presents a novel, validated HPLC method for accurately quantifying DMZ and PHENZ in various pharmaceutical formulations, including bulk powders, sachets, vials, and injectables. The chromatographic separation was achieved using a C18 column (150 x 4.6 mm, 5 μm particle size) with a mobile phase composed of phosphate buffer (pH 3.0) and methanol (70:30 v/v) at a flow rate of 1 mL/minute. UV detection was set at 250 nm. The method demonstrated linearity over a concentration range of 20-100 μg/mL for DMZ and 25-125 μg/mL for PHENZ, with correlation coefficients exceeding 0.999. Forced degradation studies were conducted under various stress conditions to assess the method's stability-indicating power. DMZ exhibited first-order degradation under acidic pH conditions. While slight degradation (2.4-3.1%) was observed under alkaline, UV, and indoor room light conditions, PHENZ remained stable. The validated HPLC method effectively quantified DMZ and PHENZ in the presence of their degradation products and impurities, demonstrating its suitability for quality control and stability studies of these combined drug formulations. https://journal.umpr.ac.id/index.php/bjop/article/view/3588Diminazene diaceturatePhenazoneHPLCStability |
| spellingShingle | Amna Mubarak Shaza Wagiealla Shantier Magdi Awadalla Mohamed Elrasheed Ahmed Gadkariem Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method Borneo Journal of Pharmacy Diminazene diaceturate Phenazone HPLC Stability |
| title | Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method |
| title_full | Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method |
| title_fullStr | Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method |
| title_full_unstemmed | Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method |
| title_short | Stability Evaluation on Diminazene Diaceturate and Phenazone in Bulk and Combined Formulations using Validated Chromatographic Method |
| title_sort | stability evaluation on diminazene diaceturate and phenazone in bulk and combined formulations using validated chromatographic method |
| topic | Diminazene diaceturate Phenazone HPLC Stability |
| url | https://journal.umpr.ac.id/index.php/bjop/article/view/3588 |
| work_keys_str_mv | AT amnamubarak stabilityevaluationondiminazenediaceturateandphenazoneinbulkandcombinedformulationsusingvalidatedchromatographicmethod AT shazawagieallashantier stabilityevaluationondiminazenediaceturateandphenazoneinbulkandcombinedformulationsusingvalidatedchromatographicmethod AT magdiawadallamohamed stabilityevaluationondiminazenediaceturateandphenazoneinbulkandcombinedformulationsusingvalidatedchromatographicmethod AT elrasheedahmedgadkariem stabilityevaluationondiminazenediaceturateandphenazoneinbulkandcombinedformulationsusingvalidatedchromatographicmethod |