Chemometrics‐Empowered Optimization of a Reliable Reversed Phase–High Performance Liquid Chromatography Method for the Simultaneous Estimation of Erythromycin and Adapalene in Pharmaceutical Nanoformulation

Author:

Shirkoli Nisha1ORCID,Mastiholimath Vinayak1ORCID

Affiliation:

1. Department of Pharmaceutical Quality Assurance KLE College of Pharmacy KLE Academy of Higher Education and Research Belagavi Karnataka India

Abstract

ABSTRACTAn innovative, simple, economical, and sensitive reversed phase–high performance liquid chromatography (RP–HPLC) chromatographic method for simultaneous analysis of erythromycin (ERY) and adapalene (ADP) in bulk and pharmaceutical nanoformulation was developed by analytical quality‐by‐design (AQbD) avenue. According to published research, there is no strategy that integrates RP–HPLC with AQbD for estimating ERY and ADP. The analysis was carried out with Box–Behnken design, which reduced trial runs and design points. Acetonitrile: orthophosphoric acid (OPA) (0.1% triethanolamine) in pH 6.2 water was used as the mobile phase. The ratio was set to 35:65 (v/v) at 0.8 mL/min flow rate to detect the analytes at 231 nm. As per the guidelines in International Conference on Harmonization Q1A (R2), the developed approach was validated. ERY and ADP regression coefficients (r2) were found to be 0.9998 and 0.9999, respectively, over 5–25 µg/mL range. Validation parameters comprising linearity, sensitivity, system suitability, precision, robustness, and accuracy were performed. To assess stability, the drugs were subjected to stress conditions (hydrolytic, oxidative, thermal, and photolytic), and drugs were most vulnerable to degrade in alkaline and oxidative conditions. A new technique successfully analyzed novel drug carriers loaded with ERY and ADP.

Publisher

Wiley

Reference40 articles.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3