Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula

A simple, easy-to-implement, and green infrared spectroscopic method was developed and validated for the quantitative determination of sildenafil citrate in tablets of unknown manufacturing formula. Homogenized tablet powder with known mass content (%, m/m) of sildenafil citrate was mixed with parac...

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Main Authors: Van Trung Bui, Cao Son Doan, Thi Thanh Vuong Tong, Dinh Chi Le
Format: Article
Language:English
Published: Wiley 2021-01-01
Series:Journal of Analytical Methods in Chemistry
Online Access:http://dx.doi.org/10.1155/2021/6616728
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author Van Trung Bui
Cao Son Doan
Thi Thanh Vuong Tong
Dinh Chi Le
author_facet Van Trung Bui
Cao Son Doan
Thi Thanh Vuong Tong
Dinh Chi Le
author_sort Van Trung Bui
collection DOAJ
description A simple, easy-to-implement, and green infrared spectroscopic method was developed and validated for the quantitative determination of sildenafil citrate in tablets of unknown manufacturing formula. Homogenized tablet powder with known mass content (%, m/m) of sildenafil citrate was mixed with paracetamol to form standard mixtures with different percentages of sildenafil citrate on the total quantity of sildenafil citrate and paracetamol (designated as R). Unknown tablet samples were finely ground and mixed with paracetamol to form test mixtures having R values about 50%. Infrared spectra of standard mixtures, measured in attenuated total reflectance mode, in the wavenumber zone from 1800 cm−1 to 1300 cm−1 were selected and processed by partial least square regression to form the calibration model for quantitation of sildenafil citrate in unknown samples. Spectral responses of test mixtures and the calibration model were used to determine the exact mass content (%, m/m) of sildenafil citrate in the powder of unknown tablet samples. The method was fully validated in terms of linearity, precision, and accuracy according to the requirements of current guidelines and was proved as reliable and suitable for the intended application.
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language English
publishDate 2021-01-01
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series Journal of Analytical Methods in Chemistry
spelling doaj-art-9f28ac6425a440faa708e6803e915c272025-02-03T05:58:26ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732021-01-01202110.1155/2021/66167286616728Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing FormulaVan Trung Bui0Cao Son Doan1Thi Thanh Vuong Tong2Dinh Chi Le3National Institute of Drug Quality Control, Ministry of Health, Hanoi, VietnamNational Institute of Drug Quality Control, Ministry of Health, Hanoi, VietnamDepartment of Analytical Chemistry and Toxicology, Hanoi University of Pharmacy, Hanoi, VietnamDepartment of Analytical Chemistry and Toxicology, Hanoi University of Pharmacy, Hanoi, VietnamA simple, easy-to-implement, and green infrared spectroscopic method was developed and validated for the quantitative determination of sildenafil citrate in tablets of unknown manufacturing formula. Homogenized tablet powder with known mass content (%, m/m) of sildenafil citrate was mixed with paracetamol to form standard mixtures with different percentages of sildenafil citrate on the total quantity of sildenafil citrate and paracetamol (designated as R). Unknown tablet samples were finely ground and mixed with paracetamol to form test mixtures having R values about 50%. Infrared spectra of standard mixtures, measured in attenuated total reflectance mode, in the wavenumber zone from 1800 cm−1 to 1300 cm−1 were selected and processed by partial least square regression to form the calibration model for quantitation of sildenafil citrate in unknown samples. Spectral responses of test mixtures and the calibration model were used to determine the exact mass content (%, m/m) of sildenafil citrate in the powder of unknown tablet samples. The method was fully validated in terms of linearity, precision, and accuracy according to the requirements of current guidelines and was proved as reliable and suitable for the intended application.http://dx.doi.org/10.1155/2021/6616728
spellingShingle Van Trung Bui
Cao Son Doan
Thi Thanh Vuong Tong
Dinh Chi Le
Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
Journal of Analytical Methods in Chemistry
title Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
title_full Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
title_fullStr Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
title_full_unstemmed Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
title_short Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula
title_sort development and validation of a simple green infrared spectroscopic method for quantitation of sildenafil citrate in siloflam tablets of unknown manufacturing formula
url http://dx.doi.org/10.1155/2021/6616728
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