Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms
Angiotensin-converting enzyme inhibitors are one of the most widely used anti-hypertensive drugs which are used to reduce hypertension. In 2018, the United States Food and Drug Administration together with the European Medicine Agency declared the presence of carcinogenic nitrosamine impurities such...
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| Format: | Article |
| Language: | English |
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The Royal Society
2022-06-01
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| Series: | Royal Society Open Science |
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| Online Access: | https://royalsocietypublishing.org/doi/10.1098/rsos.220250 |
| _version_ | 1797837618853969920 |
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| author | Soad S. Abd El-Hay Magda Elhenawee Khaled Maged Adel Ehab Ibrahim |
| author_facet | Soad S. Abd El-Hay Magda Elhenawee Khaled Maged Adel Ehab Ibrahim |
| author_sort | Soad S. Abd El-Hay |
| collection | DOAJ |
| description | Angiotensin-converting enzyme inhibitors are one of the most widely used anti-hypertensive drugs which are used to reduce hypertension. In 2018, the United States Food and Drug Administration together with the European Medicine Agency declared the presence of carcinogenic nitrosamine impurities such as nitrosodiethylamine (NDEA) in some of the products, including valsartan (VLS) and losartan (LOS), and drugs' recall procedures were started. Thus, they should be controlled to be below the acceptable cancer risk level to ensure safety of the pharmaceutical products. Therefore, sensitive and reliable analytical methods were required for detection and quantitation of NDEA in bulk and finished drug products. Green analytical chemistry has received great interest to minimize the amount of organic solvents consumed without loss in chromatographic performance. A green and sensitive HPLC method was developed for the determination of NDEA in LOS and VLS using mobile phase of 0.02 M ammonium acetate adjusted to pH 7.2 and ethanol in gradient manner. Limits of detection and limits of quantification for NDEA were estimated to be 0.2 and 0.5 µg ml−1, respectively. The standardized limits of NDEA impurity in drug substances were set as 0.56 ppm, which indicates the feasibility of its determination by the proposed conventional method without need for expensive instrumentations (e.g. MS/MS detectors) that are not found in most pharmaceutical quality control laboratories. |
| first_indexed | 2024-04-09T15:27:37Z |
| format | Article |
| id | doaj.art-19018a6f61724b39af49d457d2b95a3b |
| institution | Directory Open Access Journal |
| issn | 2054-5703 |
| language | English |
| last_indexed | 2024-04-09T15:27:37Z |
| publishDate | 2022-06-01 |
| publisher | The Royal Society |
| record_format | Article |
| series | Royal Society Open Science |
| spelling | doaj.art-19018a6f61724b39af49d457d2b95a3b2023-04-28T10:52:23ZengThe Royal SocietyRoyal Society Open Science2054-57032022-06-019610.1098/rsos.220250Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage formsSoad S. Abd El-Hay0Magda Elhenawee1Khaled Maged2Adel Ehab Ibrahim3Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, EgyptAnalytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, EgyptPharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Sinai University, El-Areesh, EgyptPharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Port-Said University, Port-Said, EgyptAngiotensin-converting enzyme inhibitors are one of the most widely used anti-hypertensive drugs which are used to reduce hypertension. In 2018, the United States Food and Drug Administration together with the European Medicine Agency declared the presence of carcinogenic nitrosamine impurities such as nitrosodiethylamine (NDEA) in some of the products, including valsartan (VLS) and losartan (LOS), and drugs' recall procedures were started. Thus, they should be controlled to be below the acceptable cancer risk level to ensure safety of the pharmaceutical products. Therefore, sensitive and reliable analytical methods were required for detection and quantitation of NDEA in bulk and finished drug products. Green analytical chemistry has received great interest to minimize the amount of organic solvents consumed without loss in chromatographic performance. A green and sensitive HPLC method was developed for the determination of NDEA in LOS and VLS using mobile phase of 0.02 M ammonium acetate adjusted to pH 7.2 and ethanol in gradient manner. Limits of detection and limits of quantification for NDEA were estimated to be 0.2 and 0.5 µg ml−1, respectively. The standardized limits of NDEA impurity in drug substances were set as 0.56 ppm, which indicates the feasibility of its determination by the proposed conventional method without need for expensive instrumentations (e.g. MS/MS detectors) that are not found in most pharmaceutical quality control laboratories.https://royalsocietypublishing.org/doi/10.1098/rsos.220250losartanvalsartannitrosodiethylamineprocess-related impuritiesgreen chromatography |
| spellingShingle | Soad S. Abd El-Hay Magda Elhenawee Khaled Maged Adel Ehab Ibrahim Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms Royal Society Open Science losartan valsartan nitrosodiethylamine process-related impurities green chromatography |
| title | Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms |
| title_full | Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms |
| title_fullStr | Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms |
| title_full_unstemmed | Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms |
| title_short | Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms |
| title_sort | cost effective green hplc determination of losartan valsartan and their nitrosodiethylamine impurity application to pharmaceutical dosage forms |
| topic | losartan valsartan nitrosodiethylamine process-related impurities green chromatography |
| url | https://royalsocietypublishing.org/doi/10.1098/rsos.220250 |
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