Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR

Abstract Background Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 perc...

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Autores principales:	Anuradha Vejendla, Subrahmanyam Talari, Raju Moturu, S. N. Murthy Boddapati, A. Emmanuel Kola
Formato:	article
Lenguaje:	EN
Publicado:	SpringerOpen 2021
Materias:	Rilpivirine Cabotegravir LCMS FTIR development Characterization Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/bb740d18053343ea90a656ec5ff22414
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spelling	oai:doaj.org-article:bb740d18053343ea90a656ec5ff224142021-11-08T11:04:35ZMethod development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR10.1186/s43094-021-00355-82314-7253https://doaj.org/article/bb740d18053343ea90a656ec5ff224142021-11-01T00:00:00Zhttps://doi.org/10.1186/s43094-021-00355-8https://doaj.org/toc/2314-7253Abstract Background Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 percent formic acid in a 20:80v/v ratio. The flow rate was kept constant at 1.0 ml/min, and detection was accomplished through absorption at 231 nm with a photodiode array detector. Results The calibration curve was linear, with a regression coefficient (R2) value of 0.999 and concentrations ranging from 30 to 450 g/ml of Rilpivirine and 20–300 g/ml of Cabotegravir. The method's LOD and LOQ were 0.375 g/ml, 1.238 g/ml, and 0.25 g/ml, 0.825 g/ml for Rilpivirine and Cabotegravir, respectively. Conclusions In the forced degradation studies, the degradants were characterized by using LCMS and FTIR. The current application was found to be simple, economical, and suitable, and validated according to ICH guidelines.Anuradha VejendlaSubrahmanyam TalariRaju MoturuS. N. Murthy BoddapatiA. Emmanuel KolaSpringerOpenarticleRilpivirineCabotegravirLCMSFTIR developmentCharacterizationTherapeutics. PharmacologyRM1-950Pharmacy and materia medicaRS1-441ENFuture Journal of Pharmaceutical Sciences, Vol 7, Iss 1, Pp 1-18 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Rilpivirine Cabotegravir LCMS FTIR development Characterization Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
spellingShingle	Rilpivirine Cabotegravir LCMS FTIR development Characterization Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441 Anuradha Vejendla Subrahmanyam Talari Raju Moturu S. N. Murthy Boddapati A. Emmanuel Kola Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
description	Abstract Background Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 percent formic acid in a 20:80v/v ratio. The flow rate was kept constant at 1.0 ml/min, and detection was accomplished through absorption at 231 nm with a photodiode array detector. Results The calibration curve was linear, with a regression coefficient (R2) value of 0.999 and concentrations ranging from 30 to 450 g/ml of Rilpivirine and 20–300 g/ml of Cabotegravir. The method's LOD and LOQ were 0.375 g/ml, 1.238 g/ml, and 0.25 g/ml, 0.825 g/ml for Rilpivirine and Cabotegravir, respectively. Conclusions In the forced degradation studies, the degradants were characterized by using LCMS and FTIR. The current application was found to be simple, economical, and suitable, and validated according to ICH guidelines.
format	article
author	Anuradha Vejendla Subrahmanyam Talari Raju Moturu S. N. Murthy Boddapati A. Emmanuel Kola
author_facet	Anuradha Vejendla Subrahmanyam Talari Raju Moturu S. N. Murthy Boddapati A. Emmanuel Kola
author_sort	Anuradha Vejendla
title	Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
title_short	Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
title_full	Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
title_fullStr	Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
title_full_unstemmed	Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR
title_sort	method development and validation for cabotegravir and rilpivirine by using hplc and its degradants are characterized by lcms and ftir
publisher	SpringerOpen
publishDate	2021
url	https://doaj.org/article/bb740d18053343ea90a656ec5ff22414
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Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR

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