Bioanalytical validated Spectrofluorimetric Method for the Determination of Prucalopride succinate in Human Urine Samples and Its Greenness Evaluation

Author:

Saad Marwa T.1,Zaazaa Hala E.2,Fattah Taghreed A.1,Boltia Shereen A.2

Affiliation:

1. National Organization for Drug Control and Research (NODCAR)

2. Cairo University Faculty of Pharmacy

Abstract

Abstract An economical & eco-friendly spectrofluorometric technique has been developed for the determination of prucalopride succinate (PRU) in human urine on the basis of drug’s native fluorescence. The type of solvent and the wavelengths of excitation and emission have been carefully selected for optimal experimental conditions. In deionized water, the fluorescence intensity was measured at λ emission 362 nm upon excitation at 310 nm. This bio-validated method was carried out using 30uL urine without carrying out any preliminary steps. The calibration curve for PRU shows a linear relationship in a concentration range of 0.75–5.5µg/mL. The validation of this proposed technique obeys EMA Guidelines for validating bioanalytical methods and the greenness assessment was evaluated according to the Analytical GAPI approach.

Publisher

Research Square Platform LLC

Reference15 articles.

1. Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?;Kaza M;J Pharm Biomed Anal,2019

2. Effect of renal impairment on the pharmacokinetics of prucalopride: a single-dose open-label phase I study;Smith WB;Drug Des Devel Ther,2012

3. Development & Validation of RP-HPLC method for estimation of prucalopride succinate in pharmaceutical dosage form;Vaibhavi N;WORLD J Pharm Pharm Sci,2020

4. Development And Validation Of A Stability Indicating Rp-Hplc Method For The Determination Of Prucalopride Succinate;Kanthale SBTS,2020

5. Pharmacokinetics and tissue distribution study of prucalopride in rats by ultra high performance liquid chromatography with tandem mass spectrometry;Zuo L;J Pharm Biomed Anal,2016

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