{"title":"利那洛肽的高效液相色谱分析与制备","authors":"Yi Zhu, T. Feng, Y. Diao, Chunyan Tu","doi":"10.4172/2155-9872.1000366","DOIUrl":null,"url":null,"abstract":"Linaclotide, a synthetic peptide, is a guanylate cyclase-C (GC-C) agonist for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. A simple, precise and selective RP-HPLC method for linaclotide analysis was developed and validated. Analysis was achieved with a SinoChrom ODS-BP column, mobile phase A and B comprised 30 mol·L-1 phosphate (pH 2.8) solution and acetonitrile respectively, gradient elution B% set to 7%?25% from 0 to 32 min and to 25% from 32 to 50 min, flow rate of 1.0 mL·min-1, oven temperature at 40?, injection volume of 20 µL, and UV detection wavelength at 214 nm. Method validation was carried out in linearity, LOD, LOQ, precision and stability. Modified method for linaclotide preparation on a preparative liquid chromatography was developed from the analytical method and applied successfully.","PeriodicalId":14865,"journal":{"name":"Journal of analytical and bioanalytical techniques","volume":"267 2 1","pages":"1-6"},"PeriodicalIF":0.0000,"publicationDate":"2017-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Analysis and Preparation of Linaclotide by High Performance Liquid Chromatography\",\"authors\":\"Yi Zhu, T. Feng, Y. Diao, Chunyan Tu\",\"doi\":\"10.4172/2155-9872.1000366\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Linaclotide, a synthetic peptide, is a guanylate cyclase-C (GC-C) agonist for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. A simple, precise and selective RP-HPLC method for linaclotide analysis was developed and validated. Analysis was achieved with a SinoChrom ODS-BP column, mobile phase A and B comprised 30 mol·L-1 phosphate (pH 2.8) solution and acetonitrile respectively, gradient elution B% set to 7%?25% from 0 to 32 min and to 25% from 32 to 50 min, flow rate of 1.0 mL·min-1, oven temperature at 40?, injection volume of 20 µL, and UV detection wavelength at 214 nm. Method validation was carried out in linearity, LOD, LOQ, precision and stability. Modified method for linaclotide preparation on a preparative liquid chromatography was developed from the analytical method and applied successfully.\",\"PeriodicalId\":14865,\"journal\":{\"name\":\"Journal of analytical and bioanalytical techniques\",\"volume\":\"267 2 1\",\"pages\":\"1-6\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-06-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of analytical and bioanalytical techniques\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4172/2155-9872.1000366\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of analytical and bioanalytical techniques","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4172/2155-9872.1000366","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1
摘要
利那克洛肽是一种合成肽，是一种鸟苷酸环化酶- c (GC-C)激动剂，用于治疗肠易激综合征伴便秘和慢性特发性便秘。建立了一种简便、精确、选择性好的反相高效液相色谱法分析利那洛肽。采用SinoChrom ODS-BP色谱柱进行分析，流动相a和B分别为30 mol·L-1磷酸(pH 2.8)溶液和乙腈，梯度洗脱B%设置为7%?0 ~ 32 min 25%， 32 ~ 50 min 25%，流速1.0 mL·min-1，烘箱温度40?，进样量20 µL，紫外检测波长214 nm。对方法进行了线性度、定量限、定量限、精密度和稳定性验证。在分析方法的基础上，建立了制备型液相色谱法制备利那洛肽的改进方法，并成功应用。
Analysis and Preparation of Linaclotide by High Performance Liquid Chromatography
Linaclotide, a synthetic peptide, is a guanylate cyclase-C (GC-C) agonist for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. A simple, precise and selective RP-HPLC method for linaclotide analysis was developed and validated. Analysis was achieved with a SinoChrom ODS-BP column, mobile phase A and B comprised 30 mol·L-1 phosphate (pH 2.8) solution and acetonitrile respectively, gradient elution B% set to 7%?25% from 0 to 32 min and to 25% from 32 to 50 min, flow rate of 1.0 mL·min-1, oven temperature at 40?, injection volume of 20 µL, and UV detection wavelength at 214 nm. Method validation was carried out in linearity, LOD, LOQ, precision and stability. Modified method for linaclotide preparation on a preparative liquid chromatography was developed from the analytical method and applied successfully.
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