A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation
Valproic acid and its derivatives are common drugs used in the treatment of epilepsy, a result of CNS disorders. Because the molecular structure of valproic acid, as a fatty acid, does not contain any chromophore groups, its peak response demanded special conditions to be detected in HPLC, ensuring...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-12-01
|
| Series: | Talanta Open |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666831924000791 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846125031113883648 |
|---|---|
| author | Abdullah H. Alluhayb Mostafa F. Al-Hakkani Mahmoud Abdulnasser Bandar R. Alsehli Mohammed S. Saddik Mohammad H.A. Hassan Sayed M Saleh |
| author_facet | Abdullah H. Alluhayb Mostafa F. Al-Hakkani Mahmoud Abdulnasser Bandar R. Alsehli Mohammed S. Saddik Mohammad H.A. Hassan Sayed M Saleh |
| author_sort | Abdullah H. Alluhayb |
| collection | DOAJ |
| description | Valproic acid and its derivatives are common drugs used in the treatment of epilepsy, a result of CNS disorders. Because the molecular structure of valproic acid, as a fatty acid, does not contain any chromophore groups, its peak response demanded special conditions to be detected in HPLC, ensuring the best precision results. Still, the current approach illustrates simple, validated procedures for conduction. The conducted chromatographic system consists of the BDS Hypersil C8, 150 × 4.6 mm, 5 µm column using a mobile phase of acetonitrile: phosphate buffer (4:6) at a detection wavelength of 215 nm at room temperature. A full method validation study was conducted and approved to ensure precise, repeatable, and accurate results by implementing system suitability parameters. In microbiological terms, a suitability test is used to validate microbiological testing methods, ensuring their efficacy despite potential interference from antimicrobial properties in the tested materials. The HPLC-UV developed and validated analytical method was evaluated, and it was found to be sensitive for use in the detection of low concentrations of methylparaben, propylparaben, and valproate with an optimum run time of six minutes. limit of detection (LODs) were statistically estimated and found to be 2.27 µg/mL, 39.77 ng/mL, and 1.84 µg/mL for methylparaben, propylparaben, and valproate, respectively. Additionally, the method demonstrated a high recovery of methylparaben, propylparaben, and valproate with an excellent closed-accuracy range (98.84% - 101.34%). An excellent regression coefficient (r) of 0.99924, 0.99998, and 0.99997 for methylparaben, valproate, and propylparaben, respectively, was achieved. Assay determination of various pharmaceutical dosage forms in the local market was implemented, yielding admirable results. |
| format | Article |
| id | doaj-art-7c5b400fa4d440319b33ae78d8d56a77 |
| institution | Kabale University |
| issn | 2666-8319 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Talanta Open |
| spelling | doaj-art-7c5b400fa4d440319b33ae78d8d56a772024-12-13T11:06:09ZengElsevierTalanta Open2666-83192024-12-0110100365A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluationAbdullah H. Alluhayb0Mostafa F. Al-Hakkani1Mahmoud Abdulnasser2Bandar R. Alsehli3Mohammed S. Saddik4Mohammad H.A. Hassan5Sayed M Saleh6Department of Chemistry, College of Science, Qassim University, Buraidah,51452, Saudi Arabia; Corresponding authors.Department of Methodology, UP Pharma, Industrial zone, Arab El Awamer, Abnoub, 76, Assiut, Egypt; Corresponding authors.Department of Methodology, UP Pharma, Industrial zone, Arab El Awamer, Abnoub, 76, Assiut, EgyptDepartment of Chemistry, Faculty of Science, Taibah University, Al-Madinah Al-Munawarah 30002, Saudi ArabiaDepartment of Pharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Sohag University, Sohag 82524, Egypt; College of Pharmacy, Al-Ayen Iraqi University, Thi-Qar, 64001, IraqDepartment of Chemistry, College of Science, Qassim University, Buraidah,51452, Saudi Arabia; Department of Methodology, UP Pharma, Industrial zone, Arab El Awamer, Abnoub, 76, Assiut, Egypt; Department of Chemistry, Faculty of Science, Taibah University, Al-Madinah Al-Munawarah 30002, Saudi Arabia; Department of Pharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Sohag University, Sohag 82524, Egypt; College of Pharmacy, Al-Ayen Iraqi University, Thi-Qar, 64001, Iraq; Department of Medical Laboratory Technology, Higher Technological Institute for Applied Health Sciences in Minya, Minya, EgyptDepartment of Chemistry, College of Science, Qassim University, Buraidah,51452, Saudi Arabia; Corresponding authors.Valproic acid and its derivatives are common drugs used in the treatment of epilepsy, a result of CNS disorders. Because the molecular structure of valproic acid, as a fatty acid, does not contain any chromophore groups, its peak response demanded special conditions to be detected in HPLC, ensuring the best precision results. Still, the current approach illustrates simple, validated procedures for conduction. The conducted chromatographic system consists of the BDS Hypersil C8, 150 × 4.6 mm, 5 µm column using a mobile phase of acetonitrile: phosphate buffer (4:6) at a detection wavelength of 215 nm at room temperature. A full method validation study was conducted and approved to ensure precise, repeatable, and accurate results by implementing system suitability parameters. In microbiological terms, a suitability test is used to validate microbiological testing methods, ensuring their efficacy despite potential interference from antimicrobial properties in the tested materials. The HPLC-UV developed and validated analytical method was evaluated, and it was found to be sensitive for use in the detection of low concentrations of methylparaben, propylparaben, and valproate with an optimum run time of six minutes. limit of detection (LODs) were statistically estimated and found to be 2.27 µg/mL, 39.77 ng/mL, and 1.84 µg/mL for methylparaben, propylparaben, and valproate, respectively. Additionally, the method demonstrated a high recovery of methylparaben, propylparaben, and valproate with an excellent closed-accuracy range (98.84% - 101.34%). An excellent regression coefficient (r) of 0.99924, 0.99998, and 0.99997 for methylparaben, valproate, and propylparaben, respectively, was achieved. Assay determination of various pharmaceutical dosage forms in the local market was implemented, yielding admirable results.http://www.sciencedirect.com/science/article/pii/S2666831924000791HPLCValidationValproic acidSodium divalproexMicrobiological suitabilityLimit of detection, LOQ |
| spellingShingle | Abdullah H. Alluhayb Mostafa F. Al-Hakkani Mahmoud Abdulnasser Bandar R. Alsehli Mohammed S. Saddik Mohammad H.A. Hassan Sayed M Saleh A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation Talanta Open HPLC Validation Valproic acid Sodium divalproex Microbiological suitability Limit of detection, LOQ |
| title | A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| title_full | A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| title_fullStr | A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| title_full_unstemmed | A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| title_short | A validated high-performance liquid chromatography-ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| title_sort | validated high performance liquid chromatography ultraviolet method for the determination of valproic acid derivatives in pharmaceutical formulations with a microbiological suitability evaluation |
| topic | HPLC Validation Valproic acid Sodium divalproex Microbiological suitability Limit of detection, LOQ |
| url | http://www.sciencedirect.com/science/article/pii/S2666831924000791 |
| work_keys_str_mv | AT abdullahhalluhayb avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mostafafalhakkani avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mahmoudabdulnasser avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT bandarralsehli avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mohammedssaddik avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mohammadhahassan avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT sayedmsaleh avalidatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT abdullahhalluhayb validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mostafafalhakkani validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mahmoudabdulnasser validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT bandarralsehli validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mohammedssaddik validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT mohammadhahassan validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation AT sayedmsaleh validatedhighperformanceliquidchromatographyultravioletmethodforthedeterminationofvalproicacidderivativesinpharmaceuticalformulationswithamicrobiologicalsuitabilityevaluation |