Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan
Impurity profiling is an important aspect in drug therapy for its safety and efficacy. The study of impurities of sartans, the first line antihypertensive drugs, has become critical due to presence of cancer causing N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodi...
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Krupanidhi College of Pharmacy
2021-12-01
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| Series: | Journal of Pharmaceutical Research |
| Online Access: | https://jopcr.com/articles/quantification-and-validation-of-a-hplc-uv-method-for-simultaneous-analysis-of-nitrosoamine-impurities-ndma-ndea-and-ndipa-in-losartan |
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| author | Santosh Patil Rajeev Chadar Ashok Prasad Poonam Koppula Santhosh Koppula |
| author_facet | Santosh Patil Rajeev Chadar Ashok Prasad Poonam Koppula Santhosh Koppula |
| author_sort | Santosh Patil |
| collection | DOAJ |
| description | Impurity profiling is an important aspect in drug therapy for its safety and efficacy. The study of impurities of sartans, the first line antihypertensive drugs, has become critical due to presence of cancer causing N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDIPA) in them, resulting from production and degradation process. These impurities have led to worldwide recall of products. Hence, a simple and accurate method has been developed and validated for simultaneous detection of NDMA, NDEA and NDIPA in Losartan using High Performance Liquid Chromatography - Ultra violet (HPLC - UV) system. The impurities were analyzed on Inertsil ODS 3V (250mm × 4.6mm, 5.0µm) analytical column by using water:methanol (60:40) as the mobile phase at a flow rate of 1.0 mL/min, with a run time of 30 mins. The method was developed for the acceptance limit of 0.64 ppm for NDMA, 0.177 ppm for NDEA and NDIPA respectively. On comparison with existing approaches, the developed method is fast, ideal for routine screening and is suitable for both laboratory and industrial uses. Keywords: Losartan, HPLC - UV, N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosodiisopropylamine |
| format | Article |
| id | doaj-art-ac42b30d20164c61a6a677fb659aa4e5 |
| institution | Kabale University |
| issn | 0973-7200 2454-8405 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | Krupanidhi College of Pharmacy |
| record_format | Article |
| series | Journal of Pharmaceutical Research |
| spelling | doaj-art-ac42b30d20164c61a6a677fb659aa4e52025-08-21T09:34:09ZengKrupanidhi College of PharmacyJournal of Pharmaceutical Research0973-72002454-84052021-12-01204434910.18579/jopcr/v20i4.MS21084Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in LosartanSantosh PatilRajeev ChadarAshok PrasadPoonam KoppulaSanthosh Koppula Impurity profiling is an important aspect in drug therapy for its safety and efficacy. The study of impurities of sartans, the first line antihypertensive drugs, has become critical due to presence of cancer causing N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDIPA) in them, resulting from production and degradation process. These impurities have led to worldwide recall of products. Hence, a simple and accurate method has been developed and validated for simultaneous detection of NDMA, NDEA and NDIPA in Losartan using High Performance Liquid Chromatography - Ultra violet (HPLC - UV) system. The impurities were analyzed on Inertsil ODS 3V (250mm × 4.6mm, 5.0µm) analytical column by using water:methanol (60:40) as the mobile phase at a flow rate of 1.0 mL/min, with a run time of 30 mins. The method was developed for the acceptance limit of 0.64 ppm for NDMA, 0.177 ppm for NDEA and NDIPA respectively. On comparison with existing approaches, the developed method is fast, ideal for routine screening and is suitable for both laboratory and industrial uses. Keywords: Losartan, HPLC - UV, N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosodiisopropylaminehttps://jopcr.com/articles/quantification-and-validation-of-a-hplc-uv-method-for-simultaneous-analysis-of-nitrosoamine-impurities-ndma-ndea-and-ndipa-in-losartan |
| spellingShingle | Santosh Patil Rajeev Chadar Ashok Prasad Poonam Koppula Santhosh Koppula Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan Journal of Pharmaceutical Research |
| title | Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan |
| title_full | Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan |
| title_fullStr | Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan |
| title_full_unstemmed | Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan |
| title_short | Quantification and Validation of a HPLC-UV Method for Simultaneous Analysis of Nitrosoamine Impurities (NDMA, NDEA and NDIPA) in Losartan |
| title_sort | quantification and validation of a hplc uv method for simultaneous analysis of nitrosoamine impurities ndma ndea and ndipa in losartan |
| url | https://jopcr.com/articles/quantification-and-validation-of-a-hplc-uv-method-for-simultaneous-analysis-of-nitrosoamine-impurities-ndma-ndea-and-ndipa-in-losartan |
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