Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma

A precise and reliable reversed-phase high-performance liquid chromatographic method with ultraviolet detection was developed and validated to determine cinitapride in human plasma. After liquid-liquid extraction, chromatographic separation was achieved on a Nucleosil C18 (25 cm × 4.6 mm, 5 µm) colu...

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Main Authors: Boovizhikannan Thangabalan, Getu Kahsay, Tadele Eticha
Format: Article
Language:English
Published: Wiley 2018-01-01
Series:Journal of Analytical Methods in Chemistry
Online Access:http://dx.doi.org/10.1155/2018/8280762
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author Boovizhikannan Thangabalan
Getu Kahsay
Tadele Eticha
author_facet Boovizhikannan Thangabalan
Getu Kahsay
Tadele Eticha
author_sort Boovizhikannan Thangabalan
collection DOAJ
description A precise and reliable reversed-phase high-performance liquid chromatographic method with ultraviolet detection was developed and validated to determine cinitapride in human plasma. After liquid-liquid extraction, chromatographic separation was achieved on a Nucleosil C18 (25 cm × 4.6 mm, 5 µm) column with an isocratic elution consisting of 10 mM ammonium acetate (pH 5.2), methanol, and acetonitrile, 40 : 50 : 10, v/v/v. The developed method was validated as per US FDA guidelines for its linearity, selectivity, sensitivity, precision, accuracy, and stability. Satisfactory findings were obtained from the validation studies. The linearity range of the method was 1 to 35 ng/mL while the extraction recovery of cinitapride in human plasma was more than 86%. The percent coefficient of variation of both intraday and interday precision was ≤7.1%.
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institution Kabale University
issn 2090-8865
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publishDate 2018-01-01
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series Journal of Analytical Methods in Chemistry
spelling doaj-art-849fcdcdb75845e2af7b57ff52f5d2732025-02-03T06:13:19ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732018-01-01201810.1155/2018/82807628280762Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human PlasmaBoovizhikannan Thangabalan0Getu Kahsay1Tadele Eticha2School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, EthiopiaSchool of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, EthiopiaSchool of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, EthiopiaA precise and reliable reversed-phase high-performance liquid chromatographic method with ultraviolet detection was developed and validated to determine cinitapride in human plasma. After liquid-liquid extraction, chromatographic separation was achieved on a Nucleosil C18 (25 cm × 4.6 mm, 5 µm) column with an isocratic elution consisting of 10 mM ammonium acetate (pH 5.2), methanol, and acetonitrile, 40 : 50 : 10, v/v/v. The developed method was validated as per US FDA guidelines for its linearity, selectivity, sensitivity, precision, accuracy, and stability. Satisfactory findings were obtained from the validation studies. The linearity range of the method was 1 to 35 ng/mL while the extraction recovery of cinitapride in human plasma was more than 86%. The percent coefficient of variation of both intraday and interday precision was ≤7.1%.http://dx.doi.org/10.1155/2018/8280762
spellingShingle Boovizhikannan Thangabalan
Getu Kahsay
Tadele Eticha
Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
Journal of Analytical Methods in Chemistry
title Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
title_full Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
title_fullStr Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
title_full_unstemmed Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
title_short Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma
title_sort development and validation of a high performance liquid chromatographic method for the determination of cinitapride in human plasma
url http://dx.doi.org/10.1155/2018/8280762
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