Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

(1) Background: The functional groups present in tranexamic acid allow direct infrared detection analysis. This study aimed to develop, apply, and validate an infrared spectrophotometry method used for qualitative and quantitative analyses of tranexamic acid in marketed tablets. (2) Methods: This wa...

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Autores principales:	Nerdy Nerdy, Linda Margata, Bunga Mari Sembiring, Selamat Ginting, Effendy De Lux Putra, Tedy Kurniawan Bakri
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	validation infrared spectrophotometry qualitative quantitative tranexamic acid Organic chemistry QD241-441
Acceso en línea:	https://doaj.org/article/afa6836668474945a29fc1f2fcb56a58
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spelling	oai:doaj.org-article:afa6836668474945a29fc1f2fcb56a582021-11-25T18:28:55ZValidation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets10.3390/molecules262269851420-3049https://doaj.org/article/afa6836668474945a29fc1f2fcb56a582021-11-01T00:00:00Zhttps://www.mdpi.com/1420-3049/26/22/6985https://doaj.org/toc/1420-3049(1) Background: The functional groups present in tranexamic acid allow direct infrared detection analysis. This study aimed to develop, apply, and validate an infrared spectrophotometry method used for qualitative and quantitative analyses of tranexamic acid in marketed tablets. (2) Methods: This was a descriptive observational study that consisted of several stages: determining the specific wavenumber for analysis, obtaining a simple linear regression equation, analyzing tranexamic acid both qualitatively and quantitatively, and validating the developed method for routine analysis. (3) Results: The peak analysis obtained a range of baseline wavenumbers from 1679.17 to 1295.25 cm<sup>−1</sup>. The regression equation obtained was Y = 310.8527 × X + 0.9718, and the coefficient of determination (R<sup>2</sup>) obtained was 0.9994. The tranexamic acids in marketed tablets overall have a similarity index value of more than 0.90 and overall have levels ranging between 97.0% and 103.0%. The infrared spectrophotometry method that was successfully developed, applied, and validated for qualitative and quantitative analyses of tranexamic acid in marketed tablets meets the requirements both qualitatively and quantitatively of the tablet monograph. (4) Conclusions: The infrared spectrophotometry method has been validated and meets the requirements for accuracy, precision, detection limit, quantitation limit, linearity, range, and specificity.Nerdy NerdyLinda MargataBunga Mari SembiringSelamat GintingEffendy De Lux PutraTedy Kurniawan BakriMDPI AGarticlevalidationinfrared spectrophotometryqualitativequantitativetranexamic acidOrganic chemistryQD241-441ENMolecules, Vol 26, Iss 6985, p 6985 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	validation infrared spectrophotometry qualitative quantitative tranexamic acid Organic chemistry QD241-441
spellingShingle	validation infrared spectrophotometry qualitative quantitative tranexamic acid Organic chemistry QD241-441 Nerdy Nerdy Linda Margata Bunga Mari Sembiring Selamat Ginting Effendy De Lux Putra Tedy Kurniawan Bakri Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
description	(1) Background: The functional groups present in tranexamic acid allow direct infrared detection analysis. This study aimed to develop, apply, and validate an infrared spectrophotometry method used for qualitative and quantitative analyses of tranexamic acid in marketed tablets. (2) Methods: This was a descriptive observational study that consisted of several stages: determining the specific wavenumber for analysis, obtaining a simple linear regression equation, analyzing tranexamic acid both qualitatively and quantitatively, and validating the developed method for routine analysis. (3) Results: The peak analysis obtained a range of baseline wavenumbers from 1679.17 to 1295.25 cm<sup>−1</sup>. The regression equation obtained was Y = 310.8527 × X + 0.9718, and the coefficient of determination (R<sup>2</sup>) obtained was 0.9994. The tranexamic acids in marketed tablets overall have a similarity index value of more than 0.90 and overall have levels ranging between 97.0% and 103.0%. The infrared spectrophotometry method that was successfully developed, applied, and validated for qualitative and quantitative analyses of tranexamic acid in marketed tablets meets the requirements both qualitatively and quantitatively of the tablet monograph. (4) Conclusions: The infrared spectrophotometry method has been validated and meets the requirements for accuracy, precision, detection limit, quantitation limit, linearity, range, and specificity.
format	article
author	Nerdy Nerdy Linda Margata Bunga Mari Sembiring Selamat Ginting Effendy De Lux Putra Tedy Kurniawan Bakri
author_facet	Nerdy Nerdy Linda Margata Bunga Mari Sembiring Selamat Ginting Effendy De Lux Putra Tedy Kurniawan Bakri
author_sort	Nerdy Nerdy
title	Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
title_short	Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
title_full	Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
title_fullStr	Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
title_full_unstemmed	Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets
title_sort	validation of the developed zero-order infrared spectrophotometry method for qualitative and quantitative analyses of tranexamic acid in marketed tablets
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/afa6836668474945a29fc1f2fcb56a58
work_keys_str_mv	AT nerdynerdy validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets AT lindamargata validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets AT bungamarisembiring validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets AT selamatginting validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets AT effendydeluxputra validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets AT tedykurniawanbakri validationofthedevelopedzeroorderinfraredspectrophotometrymethodforqualitativeandquantitativeanalysesoftranexamicacidinmarketedtablets
_version_	1718411098600767488

Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

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