稳定性指示液相色谱法测定拉米夫定和富马酸替诺福韦二氧吡酯固定剂量联合制剂的含量

R. Shedafa, P. Tibalinda, V. Manyanga, J. Sempombe, E. Kaale, C. Bonsmann, C. Haefelé, M. Chambuso
{"title":"稳定性指示液相色谱法测定拉米夫定和富马酸替诺福韦二氧吡酯固定剂量联合制剂的含量","authors":"R. Shedafa, P. Tibalinda, V. Manyanga, J. Sempombe, E. Kaale, C. Bonsmann, C. Haefelé, M. Chambuso","doi":"10.4314/ECAJPS.V17I3","DOIUrl":null,"url":null,"abstract":"This study describes the development and validation of a stability indicating high performance liquid chromatographic method for the analysis of lamivudine and tenofovir disoproxil fumarate and their degradants. The method uses a Reprosil®-pur basic C18 column (250 mm × 4.6 mm, 5 μm) maintained at 30°C, methanol and a mixture of buffers (2.3 g/L ammonium dihydrogen phosphate and 1.32 g/L of diammonium hydrogen phosphate, pH 3.9) for gradient elution at a flow rate of 1.0 mL/min, and UV detection at 270 nm. Good separation of lamivudine and tenofovir disoproxil fumarate and their potential impurities was achieved. The stability indicating ability of the developed method was validated by subjecting both active ingredients to hydrolytic and oxidative stress conditions and separating the degradation products from their respective intact drugs. The calibration curve was linear over the 80-120 μg/mL concentration range for both active ingredients with r2> 0.99. A recovery rate of 99.8 % for lamivudine and 99.3 % for tenofovir disoproxil fumarate confirmed the accuracy of the method for the simultaneous determination of both drugs in the fixed-dose combination.Keywords: Stability indicating liquid chromatography, lamivudine, tenofovir, validation","PeriodicalId":22387,"journal":{"name":"The East and Central African Journal of Pharmaceutical Sciences","volume":"104 1","pages":"70-78"},"PeriodicalIF":0.0000,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Stability Indicating Liquid Chromatographic Method for Determination of Lamivudine and Tenofovir Disoproxil Fumarate in Fixed Dose Combination Formulations\",\"authors\":\"R. Shedafa, P. Tibalinda, V. Manyanga, J. Sempombe, E. Kaale, C. Bonsmann, C. Haefelé, M. Chambuso\",\"doi\":\"10.4314/ECAJPS.V17I3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This study describes the development and validation of a stability indicating high performance liquid chromatographic method for the analysis of lamivudine and tenofovir disoproxil fumarate and their degradants. The method uses a Reprosil®-pur basic C18 column (250 mm × 4.6 mm, 5 μm) maintained at 30°C, methanol and a mixture of buffers (2.3 g/L ammonium dihydrogen phosphate and 1.32 g/L of diammonium hydrogen phosphate, pH 3.9) for gradient elution at a flow rate of 1.0 mL/min, and UV detection at 270 nm. Good separation of lamivudine and tenofovir disoproxil fumarate and their potential impurities was achieved. The stability indicating ability of the developed method was validated by subjecting both active ingredients to hydrolytic and oxidative stress conditions and separating the degradation products from their respective intact drugs. The calibration curve was linear over the 80-120 μg/mL concentration range for both active ingredients with r2> 0.99. A recovery rate of 99.8 % for lamivudine and 99.3 % for tenofovir disoproxil fumarate confirmed the accuracy of the method for the simultaneous determination of both drugs in the fixed-dose combination.Keywords: Stability indicating liquid chromatography, lamivudine, tenofovir, validation\",\"PeriodicalId\":22387,\"journal\":{\"name\":\"The East and Central African Journal of Pharmaceutical Sciences\",\"volume\":\"104 1\",\"pages\":\"70-78\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The East and Central African Journal of Pharmaceutical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4314/ECAJPS.V17I3\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The East and Central African Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4314/ECAJPS.V17I3","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 2

摘要

本研究描述了一种稳定性高的高效液相色谱分析拉米夫定和富马酸替诺福韦二氧吡酯及其降解物的方法的建立和验证。方法采用resil®-pur碱性C18色谱柱(250 mm × 4.6 mm, 5 μm),在30°C下保持,甲醇和缓冲液(2.3 g/L磷酸二氢铵和1.32 g/L磷酸氢二铵,pH 3.9)的混合物,梯度洗脱,流速1.0 mL/min, 270 nm紫外检测。对拉米夫定和富马酸替诺福韦二氧吡酯及其潜在杂质进行了较好的分离。将两种有效成分分别置于水解和氧化应激条件下,并将降解产物从各自的完整药物中分离出来,验证了所开发方法的稳定性和能力。两种有效成分在80 ~ 120 μg/mL浓度范围内均呈线性,r2> 0.99。拉米夫定的回收率为99.8%,富马酸替诺福韦二氧吡酯的回收率为99.3%,证实了该方法同时测定两种药物固定剂量组合的准确性。关键词:稳定性指示液相色谱,拉米夫定,替诺福韦,验证
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability Indicating Liquid Chromatographic Method for Determination of Lamivudine and Tenofovir Disoproxil Fumarate in Fixed Dose Combination Formulations
This study describes the development and validation of a stability indicating high performance liquid chromatographic method for the analysis of lamivudine and tenofovir disoproxil fumarate and their degradants. The method uses a Reprosil®-pur basic C18 column (250 mm × 4.6 mm, 5 μm) maintained at 30°C, methanol and a mixture of buffers (2.3 g/L ammonium dihydrogen phosphate and 1.32 g/L of diammonium hydrogen phosphate, pH 3.9) for gradient elution at a flow rate of 1.0 mL/min, and UV detection at 270 nm. Good separation of lamivudine and tenofovir disoproxil fumarate and their potential impurities was achieved. The stability indicating ability of the developed method was validated by subjecting both active ingredients to hydrolytic and oxidative stress conditions and separating the degradation products from their respective intact drugs. The calibration curve was linear over the 80-120 μg/mL concentration range for both active ingredients with r2> 0.99. A recovery rate of 99.8 % for lamivudine and 99.3 % for tenofovir disoproxil fumarate confirmed the accuracy of the method for the simultaneous determination of both drugs in the fixed-dose combination.Keywords: Stability indicating liquid chromatography, lamivudine, tenofovir, validation
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信