RP-HPLC method development and validation of Albendazole and its impurity
Oxibendazole is a type of benzimidazole that is commonly used as an antiparasitic medication for both humans and animals. However, it is also a significant impurity found in albendazole, and it is crucial to follow the ICH Q3B criteria when analysing oxibendazole impurities. Therefore, it is recomme...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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EDP Sciences
2024-01-01
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| Series: | BIO Web of Conferences |
| Online Access: | https://www.bio-conferences.org/articles/bioconf/pdf/2024/05/bioconf_rtbs2024_01046.pdf |
| _version_ | 1797352892232892416 |
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| author | Saini Geetanjali Singh Bhupendra Vyas Manish Durgapal Sumit Rangra Naresh Suttee Ashish |
| author_facet | Saini Geetanjali Singh Bhupendra Vyas Manish Durgapal Sumit Rangra Naresh Suttee Ashish |
| author_sort | Saini Geetanjali |
| collection | DOAJ |
| description | Oxibendazole is a type of benzimidazole that is commonly used as an antiparasitic medication for both humans and animals. However, it is also a significant impurity found in albendazole, and it is crucial to follow the ICH Q3B criteria when analysing oxibendazole impurities. Therefore, it is recommended to use a simple, fast, sensitive, and precise RP-HPLC approach to identify oxibendazole impurities in bulk and pharmaceutical formulations of albendazole.To separate the oxibendazole impurity, acetonitrile and 10 nM potassium phosphate were used as a mobile phase. Orthophosphoric acid was used to accurately adjust the pH of the mobile phase to 2.03, ensuring optimal conditions. A nucleosil C18 column (250 x 4.6 mm, 5 µm) was used for the separation process, and it effectively provided the necessary separation. The gradient elution was set at a wavelength of 235 nm and a flow rate of 1 mL/min. The analytical technique was successfully designed and validated. The AQbD technique was used to optimize the analytical conditions for the suggested methodology, and the Design Expert 13® trial version was used for the central composite design optimization of analytical conditions. The procedure's linearity was verified using a regression coefficient of 0.999 within a working range of 0.5 to 3 μg/ml. Accuracy research showed results of 99.94–100.10% at 50, 100, and 150% levels of the working concentration. The oxibendazole impurity's average retention time was found to be 6.40 minutes, with a relative standard deviation of less than 2%, indicating high accuracy. The limits of detection (LOD) and quantification (LOQ) were found to be 0.073 and 0.091 μg/ml, respectively. Following the ICH Q2(R1) criteria, other validation criteria, such as robustness, were also evaluated. In conclusion, the proposed approach is suitable for analysing albendazole and oxibendazole in bulk and pharmaceutical formulations, making it ideal for detecting oxibendazole impurities. |
| first_indexed | 2024-03-08T13:23:19Z |
| format | Article |
| id | doaj.art-319f3e7b966549ddbf66bff8eb1aa799 |
| institution | Directory Open Access Journal |
| issn | 2117-4458 |
| language | English |
| last_indexed | 2024-03-08T13:23:19Z |
| publishDate | 2024-01-01 |
| publisher | EDP Sciences |
| record_format | Article |
| series | BIO Web of Conferences |
| spelling | doaj.art-319f3e7b966549ddbf66bff8eb1aa7992024-01-17T15:02:13ZengEDP SciencesBIO Web of Conferences2117-44582024-01-01860104610.1051/bioconf/20248601046bioconf_rtbs2024_01046RP-HPLC method development and validation of Albendazole and its impuritySaini Geetanjali0Singh Bhupendra1Vyas Manish2Durgapal Sumit3Rangra Naresh4Suttee Ashish5College of Pharmacy, Teerthankar Mahaveer UniversityCollege of Pharmacy, Teerthankar Mahaveer UniversitySchool of Pharmaceutical Sciences. Lovely Professional UniversityCollege of Pharmacy, Teerthankar Mahaveer UniversityISF College of PharmacyCollege of Pharmacy, Teerthankar Mahaveer UniversityOxibendazole is a type of benzimidazole that is commonly used as an antiparasitic medication for both humans and animals. However, it is also a significant impurity found in albendazole, and it is crucial to follow the ICH Q3B criteria when analysing oxibendazole impurities. Therefore, it is recommended to use a simple, fast, sensitive, and precise RP-HPLC approach to identify oxibendazole impurities in bulk and pharmaceutical formulations of albendazole.To separate the oxibendazole impurity, acetonitrile and 10 nM potassium phosphate were used as a mobile phase. Orthophosphoric acid was used to accurately adjust the pH of the mobile phase to 2.03, ensuring optimal conditions. A nucleosil C18 column (250 x 4.6 mm, 5 µm) was used for the separation process, and it effectively provided the necessary separation. The gradient elution was set at a wavelength of 235 nm and a flow rate of 1 mL/min. The analytical technique was successfully designed and validated. The AQbD technique was used to optimize the analytical conditions for the suggested methodology, and the Design Expert 13® trial version was used for the central composite design optimization of analytical conditions. The procedure's linearity was verified using a regression coefficient of 0.999 within a working range of 0.5 to 3 μg/ml. Accuracy research showed results of 99.94–100.10% at 50, 100, and 150% levels of the working concentration. The oxibendazole impurity's average retention time was found to be 6.40 minutes, with a relative standard deviation of less than 2%, indicating high accuracy. The limits of detection (LOD) and quantification (LOQ) were found to be 0.073 and 0.091 μg/ml, respectively. Following the ICH Q2(R1) criteria, other validation criteria, such as robustness, were also evaluated. In conclusion, the proposed approach is suitable for analysing albendazole and oxibendazole in bulk and pharmaceutical formulations, making it ideal for detecting oxibendazole impurities.https://www.bio-conferences.org/articles/bioconf/pdf/2024/05/bioconf_rtbs2024_01046.pdf |
| spellingShingle | Saini Geetanjali Singh Bhupendra Vyas Manish Durgapal Sumit Rangra Naresh Suttee Ashish RP-HPLC method development and validation of Albendazole and its impurity BIO Web of Conferences |
| title | RP-HPLC method development and validation of Albendazole and its impurity |
| title_full | RP-HPLC method development and validation of Albendazole and its impurity |
| title_fullStr | RP-HPLC method development and validation of Albendazole and its impurity |
| title_full_unstemmed | RP-HPLC method development and validation of Albendazole and its impurity |
| title_short | RP-HPLC method development and validation of Albendazole and its impurity |
| title_sort | rp hplc method development and validation of albendazole and its impurity |
| url | https://www.bio-conferences.org/articles/bioconf/pdf/2024/05/bioconf_rtbs2024_01046.pdf |
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