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Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms

AIM AND BACKGROUND: To develop and validate a simple, precise, accurate, and stability indicating a UV-method for estimation of Telmisartan (TELM). UV, HPLC, HPTLC, and many more experiments were carried out by taking single drug and also by combining with other drugs. However, Such type of studies...

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Autores principales: Patel, Komal, Dhudasia, Komal, Patel, Amit, Dave, Jayant, Patel, Chaganbhai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658074/
https://www.ncbi.nlm.nih.gov/pubmed/23781466
http://dx.doi.org/10.4103/2229-4708.93396
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author Patel, Komal
Dhudasia, Komal
Patel, Amit
Dave, Jayant
Patel, Chaganbhai
author_facet Patel, Komal
Dhudasia, Komal
Patel, Amit
Dave, Jayant
Patel, Chaganbhai
author_sort Patel, Komal
collection PubMed
description AIM AND BACKGROUND: To develop and validate a simple, precise, accurate, and stability indicating a UV-method for estimation of Telmisartan (TELM). UV, HPLC, HPTLC, and many more experiments were carried out by taking single drug and also by combining with other drugs. However, Such type of studies was not reported. MATERIALS AND METHODS: In both methods, TELM has the absorbance maxima at 296 nm. Method A involves method development and validation and Method B involves forced degradation study. In these methods, methanol was used as a solvent. Linearity was observed in the concentration range of 4–16 μg/ml. Validation experiments were performed to demonstrate system suitability, specificity, precision, linearity, accuracy, robustness, LOD, and LOQ as per International Conference on Harmonization guidelines. Furthermore stability studies of TELM were carried out under acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per stability indicating assay methods. RESULTS: The results of analysis have been validated, and recovery studies were carried out using a standard addition method by adding specific drug amount (80%, 100%, and 120%) and show recovery studies in the range (99.26–101.26)%. CONCLUSION: The proposed method can be successfully applied for method development, validation, and stability study of TELM.
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spelling pubmed-36580742013-06-18 Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms Patel, Komal Dhudasia, Komal Patel, Amit Dave, Jayant Patel, Chaganbhai Pharm Methods Original Article AIM AND BACKGROUND: To develop and validate a simple, precise, accurate, and stability indicating a UV-method for estimation of Telmisartan (TELM). UV, HPLC, HPTLC, and many more experiments were carried out by taking single drug and also by combining with other drugs. However, Such type of studies was not reported. MATERIALS AND METHODS: In both methods, TELM has the absorbance maxima at 296 nm. Method A involves method development and validation and Method B involves forced degradation study. In these methods, methanol was used as a solvent. Linearity was observed in the concentration range of 4–16 μg/ml. Validation experiments were performed to demonstrate system suitability, specificity, precision, linearity, accuracy, robustness, LOD, and LOQ as per International Conference on Harmonization guidelines. Furthermore stability studies of TELM were carried out under acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per stability indicating assay methods. RESULTS: The results of analysis have been validated, and recovery studies were carried out using a standard addition method by adding specific drug amount (80%, 100%, and 120%) and show recovery studies in the range (99.26–101.26)%. CONCLUSION: The proposed method can be successfully applied for method development, validation, and stability study of TELM. Medknow Publications & Media Pvt Ltd 2011 /pmc/articles/PMC3658074/ /pubmed/23781466 http://dx.doi.org/10.4103/2229-4708.93396 Text en Copyright: © Pharmaceutical Methods http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Patel, Komal
Dhudasia, Komal
Patel, Amit
Dave, Jayant
Patel, Chaganbhai
Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title_full Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title_fullStr Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title_full_unstemmed Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title_short Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms
title_sort stress degradation studies on telmisartan and development of a validated method by uv spectrophotometry in bulk and pharmaceutical dosage forms
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658074/
https://www.ncbi.nlm.nih.gov/pubmed/23781466
http://dx.doi.org/10.4103/2229-4708.93396
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