Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms
A rapid, simple, accurate, precise, economical, robust, and stability indicating reverse phase HPLC-PDA procedure has been developed and validated for the determination of trandolapril. The trandolapril was separated isocratically on Hypersil-Gold C18 column (250 mm × 4.6 mm, 5 μm) with a mobile pha...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2015/820517 |
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| author | Leena A. Al-Hawash Ashok K. Shakya Maher L. Saleem |
| author_facet | Leena A. Al-Hawash Ashok K. Shakya Maher L. Saleem |
| author_sort | Leena A. Al-Hawash |
| collection | DOAJ |
| description | A rapid, simple, accurate, precise, economical, robust, and stability indicating reverse phase HPLC-PDA procedure has been developed and validated for the determination of trandolapril. The trandolapril was separated isocratically on Hypersil-Gold C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of 50% acetonitrile and 50% water (containing 0.025% triethylamine, pH 3.0±0.1), at 25±2°C. Retention time of the drug was ~4.6 min. The eluted compounds were monitored and identified at 210 nm. The linearity of the method was excellent (r2>0.9999) over the concentration range of 1–24 μg/mL; the limit of detection (LOD) and limit of quantitation (LOQ) were 0.0566 μg/mL and 0.1715 μg/mL, respectively. The overall precision was less than 2%. Mean recovery of trandolapril was more than 99%; no interference was found from the component present in the preparation. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different oxidative products on exposure to hydrogen peroxide. Slight degradation was observed in acidic condition. Degradation was higher in the alkaline condition compared to other conditions. The robustness of the method was studied using factorial design experiment. |
| format | Article |
| id | doaj-art-b3770b966ec144719a2007dafc3583f3 |
| institution | Kabale University |
| issn | 1687-8760 1687-8779 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-b3770b966ec144719a2007dafc3583f32025-02-03T01:04:58ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792015-01-01201510.1155/2015/820517820517Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage FormsLeena A. Al-Hawash0Ashok K. Shakya1Maher L. Saleem2Faculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, P.O. Box 263, Amman 19328, JordanFaculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, P.O. Box 263, Amman 19328, JordanFaculty of Pharmacy and Medical Sciences, Al-Ahliyya Amman University, P.O. Box 263, Amman 19328, JordanA rapid, simple, accurate, precise, economical, robust, and stability indicating reverse phase HPLC-PDA procedure has been developed and validated for the determination of trandolapril. The trandolapril was separated isocratically on Hypersil-Gold C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of 50% acetonitrile and 50% water (containing 0.025% triethylamine, pH 3.0±0.1), at 25±2°C. Retention time of the drug was ~4.6 min. The eluted compounds were monitored and identified at 210 nm. The linearity of the method was excellent (r2>0.9999) over the concentration range of 1–24 μg/mL; the limit of detection (LOD) and limit of quantitation (LOQ) were 0.0566 μg/mL and 0.1715 μg/mL, respectively. The overall precision was less than 2%. Mean recovery of trandolapril was more than 99%; no interference was found from the component present in the preparation. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different oxidative products on exposure to hydrogen peroxide. Slight degradation was observed in acidic condition. Degradation was higher in the alkaline condition compared to other conditions. The robustness of the method was studied using factorial design experiment.http://dx.doi.org/10.1155/2015/820517 |
| spellingShingle | Leena A. Al-Hawash Ashok K. Shakya Maher L. Saleem Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms International Journal of Analytical Chemistry |
| title | Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms |
| title_full | Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms |
| title_fullStr | Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms |
| title_full_unstemmed | Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms |
| title_short | Stability-Indicating HPLC Determination of Trandolapril in Bulk Drug and Pharmaceutical Dosage Forms |
| title_sort | stability indicating hplc determination of trandolapril in bulk drug and pharmaceutical dosage forms |
| url | http://dx.doi.org/10.1155/2015/820517 |
| work_keys_str_mv | AT leenaaalhawash stabilityindicatinghplcdeterminationoftrandolaprilinbulkdrugandpharmaceuticaldosageforms AT ashokkshakya stabilityindicatinghplcdeterminationoftrandolaprilinbulkdrugandpharmaceuticaldosageforms AT maherlsaleem stabilityindicatinghplcdeterminationoftrandolaprilinbulkdrugandpharmaceuticaldosageforms |