{"title":"阿坎戊酸钙的合成纯化及药物剂型的RP-HPLC评价","authors":"A. Ramazani, M. Rezaei, F. Gouranlou","doi":"10.22034/IJPS.2019.101368.1517","DOIUrl":null,"url":null,"abstract":"The purpose of this study is Acamprosate Calcium synthesis of 3-Aminopropane-1-sulfonic acid (Homotaurine) and validation of assay test in the delayed-release tablets by HPLC without organic solvents. The assay method by HPLC was found to be linear in the concentration range of 50 to 200 µg/mL. Successful separation was achieved by isocratic elution on a Phenomenex® C18 column (250 mm × 4.6 mm, 5μm).The mobile phase was triethylammonium phosphate buffer pH: 4.0 (100%) at the flow rate of 1 mL/min using UV detection at 210 nm, column oven temperature 25oC and injection volume 20 𝜇L. The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.36-100.60%. The LOD and LOQ were found to 0.012 μg/mL and 0.042 μg/mL. All the parameters of validation were in the acceptance range. This developed method was successfully applied for estimate the amount of Acamprosate Calcium in the tablets.","PeriodicalId":14582,"journal":{"name":"Iranian Journal of Pharmaceutical Sciences","volume":"16 1","pages":"19-28"},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC in Pharmaceutical Dosage forms\",\"authors\":\"A. Ramazani, M. Rezaei, F. Gouranlou\",\"doi\":\"10.22034/IJPS.2019.101368.1517\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The purpose of this study is Acamprosate Calcium synthesis of 3-Aminopropane-1-sulfonic acid (Homotaurine) and validation of assay test in the delayed-release tablets by HPLC without organic solvents. The assay method by HPLC was found to be linear in the concentration range of 50 to 200 µg/mL. Successful separation was achieved by isocratic elution on a Phenomenex® C18 column (250 mm × 4.6 mm, 5μm).The mobile phase was triethylammonium phosphate buffer pH: 4.0 (100%) at the flow rate of 1 mL/min using UV detection at 210 nm, column oven temperature 25oC and injection volume 20 𝜇L. The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.36-100.60%. The LOD and LOQ were found to 0.012 μg/mL and 0.042 μg/mL. All the parameters of validation were in the acceptance range. This developed method was successfully applied for estimate the amount of Acamprosate Calcium in the tablets.\",\"PeriodicalId\":14582,\"journal\":{\"name\":\"Iranian Journal of Pharmaceutical Sciences\",\"volume\":\"16 1\",\"pages\":\"19-28\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Iranian Journal of Pharmaceutical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22034/IJPS.2019.101368.1517\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Iranian Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22034/IJPS.2019.101368.1517","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
摘要
本研究采用无有机溶剂高效液相色谱法合成阿康戊酸钙缓释片中的3-氨基丙烷-1-磺酸(高牛磺酸)，并对该缓释片的测定方法进行验证。HPLC法在50 ~ 200µg/mL浓度范围内呈线性。在Phenomenex®C18色谱柱(250 mm × 4.6 mm, 5μm)上进行等温洗脱，分离成功。流动相为磷酸三乙胺缓冲液pH: 4.0(100%)，流速为1 mL/min，紫外检测波长为210 nm，柱箱温度为25℃，进样量为20𝜇L。分析结果得到了回收率研究的验证。回收率为99.36 ~ 100.60%。定量限和定量限分别为0.012 μg/mL和0.042 μg/mL。验证参数均在可接受范围内。该方法成功地用于测定阿坎普罗酸钙片的含量。
Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC in Pharmaceutical Dosage forms
The purpose of this study is Acamprosate Calcium synthesis of 3-Aminopropane-1-sulfonic acid (Homotaurine) and validation of assay test in the delayed-release tablets by HPLC without organic solvents. The assay method by HPLC was found to be linear in the concentration range of 50 to 200 µg/mL. Successful separation was achieved by isocratic elution on a Phenomenex® C18 column (250 mm × 4.6 mm, 5μm).The mobile phase was triethylammonium phosphate buffer pH: 4.0 (100%) at the flow rate of 1 mL/min using UV detection at 210 nm, column oven temperature 25oC and injection volume 20 𝜇L. The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.36-100.60%. The LOD and LOQ were found to 0.012 μg/mL and 0.042 μg/mL. All the parameters of validation were in the acceptance range. This developed method was successfully applied for estimate the amount of Acamprosate Calcium in the tablets.
期刊介绍：
Iranian Journal of Pharmaceutical Sciences (IJPS) is an open access, internationally peer-reviewed journal that seeks to publish research articles in different pharmaceutical sciences subdivisions: pharmacology and toxicology, nanotechnology, pharmaceutics, natural products, biotechnology, pharmaceutical chemistry, clinical pharmacy and other pharmacy related topics. Each issue of the journal contents 16 outstanding research articles in area of pharmaceutical sciences plus an editorial written by the IJPS editors on one of the most up to date advances topics in pharmacy. All articles published by IJPS would be permanently accessible online freely without any subscription charges. Authors of the published articles have granted the right to use and disseminate their article to third parties.
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