V. Kirakosyan, S. M. Vardapetyan, Lusine H. Varderesyan, A. Tsaturyan
{"title":"建立高效液相色谱法快速测定盐酸二甲双胍、氯沙坦钾、缬沙坦和雷尼替丁药材原料及其制品中n -亚硝基二甲胺杂质含量的方法","authors":"V. Kirakosyan, S. M. Vardapetyan, Lusine H. Varderesyan, A. Tsaturyan","doi":"10.46991/pysu:b/2021.55.3.296","DOIUrl":null,"url":null,"abstract":"In this study, chromatographic conditions were developed for the separation and quantification of N-nitrosodimethylamine (NDMA) by HPLC. Our method would be useful for the rapid screening and quantification of NDMA impurity in Metformin hydrochloride, Losartan potassium, Valsartan and Ranitidine drugs substance and its products. The chromatographic separation was achieved on a Phenomenex C18 column (250 mm, 5 µm, 4.6 mm) by multistep gradient elution, using a water-acetonitrile mobile phase containing 0.1% formic acid, which provided better c hromatographic separation. Column temperature was maintained at 30℃; mobile phase flow rate: 1 mL/min; wavelength: 254 nm; and injection volume of 20 μL.","PeriodicalId":20692,"journal":{"name":"Proceedings of the YSU B: Chemical and Biological Sciences","volume":"8 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"DEVELOPMENT OF A RAPID AND EFFICIENT METHOD FOR QUANTITATIVE DETERMINATION OF N-NITROSODIMETHYLAMINE IMPURITY BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN METFORMIN HYDROCHLORIDE, LOSARTAN POTASSIUM, VALSARTAN AND RANITIDINE MEDICINAL RAW MATERIALS AND ITS PRODUCTS\",\"authors\":\"V. Kirakosyan, S. M. Vardapetyan, Lusine H. Varderesyan, A. Tsaturyan\",\"doi\":\"10.46991/pysu:b/2021.55.3.296\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In this study, chromatographic conditions were developed for the separation and quantification of N-nitrosodimethylamine (NDMA) by HPLC. Our method would be useful for the rapid screening and quantification of NDMA impurity in Metformin hydrochloride, Losartan potassium, Valsartan and Ranitidine drugs substance and its products. The chromatographic separation was achieved on a Phenomenex C18 column (250 mm, 5 µm, 4.6 mm) by multistep gradient elution, using a water-acetonitrile mobile phase containing 0.1% formic acid, which provided better c hromatographic separation. Column temperature was maintained at 30℃; mobile phase flow rate: 1 mL/min; wavelength: 254 nm; and injection volume of 20 μL.\",\"PeriodicalId\":20692,\"journal\":{\"name\":\"Proceedings of the YSU B: Chemical and Biological Sciences\",\"volume\":\"8 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-12-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Proceedings of the YSU B: Chemical and Biological Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.46991/pysu:b/2021.55.3.296\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Proceedings of the YSU B: Chemical and Biological Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.46991/pysu:b/2021.55.3.296","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
DEVELOPMENT OF A RAPID AND EFFICIENT METHOD FOR QUANTITATIVE DETERMINATION OF N-NITROSODIMETHYLAMINE IMPURITY BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN METFORMIN HYDROCHLORIDE, LOSARTAN POTASSIUM, VALSARTAN AND RANITIDINE MEDICINAL RAW MATERIALS AND ITS PRODUCTS
In this study, chromatographic conditions were developed for the separation and quantification of N-nitrosodimethylamine (NDMA) by HPLC. Our method would be useful for the rapid screening and quantification of NDMA impurity in Metformin hydrochloride, Losartan potassium, Valsartan and Ranitidine drugs substance and its products. The chromatographic separation was achieved on a Phenomenex C18 column (250 mm, 5 µm, 4.6 mm) by multistep gradient elution, using a water-acetonitrile mobile phase containing 0.1% formic acid, which provided better c hromatographic separation. Column temperature was maintained at 30℃; mobile phase flow rate: 1 mL/min; wavelength: 254 nm; and injection volume of 20 μL.
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