Response surface methodology-based quantification of lamivudine and zidovudine using reverse-phase high-performance liquid chromatography in pharmaceutical formulation

IF 0.2 Q4 PHARMACOLOGY & PHARMACY
Anjali Chauhan, Neeti Yadav, Aarchika Shah, Darshil Shah, D. Maheshwari, J. Shah
{"title":"Response surface methodology-based quantification of lamivudine and zidovudine using reverse-phase high-performance liquid chromatography in pharmaceutical formulation","authors":"Anjali Chauhan, Neeti Yadav, Aarchika Shah, Darshil Shah, D. Maheshwari, J. Shah","doi":"10.4103/ajprhc.ajprhc_74_22","DOIUrl":null,"url":null,"abstract":"Objective: A novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for estimation of lamivudine and zidovudine by using an experimental design approach applying the response surface technique was developed and validated using a C18 column and its application in marketed formulation. Multivariate optimization of experimental conditions was achieved using experimental design employing organic content in the mobile phase, pH, and flow rate of the mobile phase as three independent variables. The aim of this study was to apply response surface methodology and to study the effect of the independent variables on the separation and estimation of both drugs by the RP-HPLC method using a faced central composite experimental design. Materials and Methods: Derringer's desirability function was used to optimize the retention period of the last eluting peak and peak symmetry, and it was discovered that the optimal conditions were potassium dihydrogen phosphate buffer and acetonitrile in an isocratic ratio of 55:45 w/v, pH 3.5, and 0.4 ml/min flow rate. Baseline separation of both medications with good resolution and a run time of more than 7 min was accomplished using this ideal condition. Results: For lamivudine and zidovudine, a linear response was seen over the concentration range of 2–12 and 4–24 μg/mL, respectively. Lamivudine's limit of detection and limit of quantitation were determined to be 3.08 and 9.18 μg/mL, respectively, whereas zidovudine's values were 3.24 and 10.17 μg/mL. According to the ICH guidelines acceptance criteria for linearity, accuracy, precision, specificity, and robustness, the method was successfully validated.","PeriodicalId":8534,"journal":{"name":"Asian Journal of Pharmaceutical Research and Health Care","volume":null,"pages":null},"PeriodicalIF":0.2000,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asian Journal of Pharmaceutical Research and Health Care","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/ajprhc.ajprhc_74_22","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Objective: A novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for estimation of lamivudine and zidovudine by using an experimental design approach applying the response surface technique was developed and validated using a C18 column and its application in marketed formulation. Multivariate optimization of experimental conditions was achieved using experimental design employing organic content in the mobile phase, pH, and flow rate of the mobile phase as three independent variables. The aim of this study was to apply response surface methodology and to study the effect of the independent variables on the separation and estimation of both drugs by the RP-HPLC method using a faced central composite experimental design. Materials and Methods: Derringer's desirability function was used to optimize the retention period of the last eluting peak and peak symmetry, and it was discovered that the optimal conditions were potassium dihydrogen phosphate buffer and acetonitrile in an isocratic ratio of 55:45 w/v, pH 3.5, and 0.4 ml/min flow rate. Baseline separation of both medications with good resolution and a run time of more than 7 min was accomplished using this ideal condition. Results: For lamivudine and zidovudine, a linear response was seen over the concentration range of 2–12 and 4–24 μg/mL, respectively. Lamivudine's limit of detection and limit of quantitation were determined to be 3.08 and 9.18 μg/mL, respectively, whereas zidovudine's values were 3.24 and 10.17 μg/mL. According to the ICH guidelines acceptance criteria for linearity, accuracy, precision, specificity, and robustness, the method was successfully validated.
基于响应面法的反相高效液相色谱法定量拉米夫定和齐多夫定
目的:建立反相高效液相色谱法(RP-HPLC)测定拉米夫定和齐多夫定含量的实验设计方法,并利用C18色谱柱对其进行验证。以流动相有机含量、pH、流动相流速为3个自变量进行实验设计,对实验条件进行多元优化。本研究的目的是应用响应面法,采用面中心复合实验设计,研究自变量对两种药物分离和估计的影响。材料与方法:采用Derringer期望函数优化最后一个洗脱峰的保留时间和峰的对称性,发现最佳条件为磷酸二氢钾缓冲液与乙腈的等密度比为55:45 w/v, pH为3.5,流速为0.4 ml/min。在这种理想条件下,两种药物的基线分离具有良好的分辨率和超过7分钟的运行时间。结果:拉米夫定和齐多夫定在2 ~ 12和4 ~ 24 μg/mL范围内呈线性关系;拉米夫定的检测限和定量限分别为3.08和9.18 μg/mL,齐多夫定的检测限和定量限分别为3.24和10.17 μg/mL。根据ICH指南的线性、准确度、精密度、特异性和稳健性验收标准,成功验证了该方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
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:481959085
Book学术官方微信