Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations
Abstract This study presents a novel and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of peramivir and its process-related impurity, 1H-1,2,4-triazole-1-carboximidamide, in bulk drug substances and injectable formulations. Chromatographic separ...
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| Format: | Article |
| Language: | English |
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Springer
2025-05-01
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| Series: | Discover Chemistry |
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| Online Access: | https://doi.org/10.1007/s44371-025-00211-1 |
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| author | Anitha Nandagopal Nemala Appala Raju |
| author_facet | Anitha Nandagopal Nemala Appala Raju |
| author_sort | Anitha Nandagopal |
| collection | DOAJ |
| description | Abstract This study presents a novel and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of peramivir and its process-related impurity, 1H-1,2,4-triazole-1-carboximidamide, in bulk drug substances and injectable formulations. Chromatographic separation was achieved using an Agilent Eclipse-XDB C18 column and a mobile phase consisting of potassium dihydrogen phosphate buffer (pH 3.2) and acetonitrile in a 50:50 (v/v) ratio, at a flow rate of 1.0 mL/min. Detection was performed using a photodiode array (PDA) detector at 260 nm. The method was validated according to ICH Q2(R2) guidelines for specificity, linearity, limits of detection (LOD) and quantification (LOQ), system suitability, precision, accuracy, robustness, and stability. Results demonstrated that the method is precise, reproducible, and reliable for simultaneous estimation of peramivir and its impurity, offering significant utility for pharmaceutical quality control and research purposes. |
| format | Article |
| id | doaj-art-bde0c10b134f4d08a5692a3f666d66b0 |
| institution | DOAJ |
| issn | 3005-1193 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Springer |
| record_format | Article |
| series | Discover Chemistry |
| spelling | doaj-art-bde0c10b134f4d08a5692a3f666d66b02025-08-20T03:16:47ZengSpringerDiscover Chemistry3005-11932025-05-012111210.1007/s44371-025-00211-1Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparationsAnitha Nandagopal0Nemala Appala Raju1Department of Pharmacology, Sultan-Ul-Uloom College of PharmacyDepartment of Pharmacognosy, Sultan-Ul-Uloom College of PharmacyAbstract This study presents a novel and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of peramivir and its process-related impurity, 1H-1,2,4-triazole-1-carboximidamide, in bulk drug substances and injectable formulations. Chromatographic separation was achieved using an Agilent Eclipse-XDB C18 column and a mobile phase consisting of potassium dihydrogen phosphate buffer (pH 3.2) and acetonitrile in a 50:50 (v/v) ratio, at a flow rate of 1.0 mL/min. Detection was performed using a photodiode array (PDA) detector at 260 nm. The method was validated according to ICH Q2(R2) guidelines for specificity, linearity, limits of detection (LOD) and quantification (LOQ), system suitability, precision, accuracy, robustness, and stability. Results demonstrated that the method is precise, reproducible, and reliable for simultaneous estimation of peramivir and its impurity, offering significant utility for pharmaceutical quality control and research purposes.https://doi.org/10.1007/s44371-025-00211-1Peramivir1H-1,2,4-triazole-1-carboximidamideRP-HPLCParenteral |
| spellingShingle | Anitha Nandagopal Nemala Appala Raju Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations Discover Chemistry Peramivir 1H-1,2,4-triazole-1-carboximidamide RP-HPLC Parenteral |
| title | Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations |
| title_full | Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations |
| title_fullStr | Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations |
| title_full_unstemmed | Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations |
| title_short | Novel RP-HPLC method for quantification of peramivir and its impurity (1H-1,2,4-triazole-1-carboximidamide) in bulk and injectable preparations |
| title_sort | novel rp hplc method for quantification of peramivir and its impurity 1h 1 2 4 triazole 1 carboximidamide in bulk and injectable preparations |
| topic | Peramivir 1H-1,2,4-triazole-1-carboximidamide RP-HPLC Parenteral |
| url | https://doi.org/10.1007/s44371-025-00211-1 |
| work_keys_str_mv | AT anithanandagopal novelrphplcmethodforquantificationofperamiviranditsimpurity1h124triazole1carboximidamideinbulkandinjectablepreparations AT nemalaappalaraju novelrphplcmethodforquantificationofperamiviranditsimpurity1h124triazole1carboximidamideinbulkandinjectablepreparations |