New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation

Abstract Background Mifepristone is progestational and glucocorticoid hormone antagonist. The objective of this study is to develop simple and economical stability indicating RP-HPLC method for the determination of mifepristone in bulk and tablet formulation. Result The chromatographic separation wa...

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Autores principales:	Mohammad Mojeeb Gulzar Khan, Mohammad Faizan Saadique Deshmukh, Sandip Dinkar Firke, Abdul Talib Abdul Wahab, Mohan Ganpatrao Kalaskar, Atul Arun Shirkhedkar
Formato:	article
Lenguaje:	EN
Publicado:	SpringerOpen 2021
Materias:	Mifepristone Stability indicating RP-HPLC method Forced degradation studies Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/95aae83e816140e39d43cd909b62b8d0
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spelling	oai:doaj.org-article:95aae83e816140e39d43cd909b62b8d02021-11-08T11:04:35ZNew stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation10.1186/s43094-021-00370-92314-7253https://doaj.org/article/95aae83e816140e39d43cd909b62b8d02021-11-01T00:00:00Zhttps://doi.org/10.1186/s43094-021-00370-9https://doaj.org/toc/2314-7253Abstract Background Mifepristone is progestational and glucocorticoid hormone antagonist. The objective of this study is to develop simple and economical stability indicating RP-HPLC method for the determination of mifepristone in bulk and tablet formulation. Result The chromatographic separation was achieved on Qualisil BDS C8 column with mobile phase containing of mixture of Buffer (Potassium dihydrogen ortho phosphate, pH to 3.0 with ortho phosphoric acid) and Organic Solvent (Acetonitrile) 60:40 v/v pumped at flow rate 0.6 mL min−1. The detection of elute was performed using PDA detector at 305 nm. Mifepristone was eluted at 8.67 min. According to international conference on harmonization Q2(R1) guideline, method was validated and shows satisfactory results for accuracy, precision, linearity, ruggedness, robustness, detection limit, quantitation limit. The method indicated to be linear in the series of concentration 3–18 µg mL−1, and correlation coefficient was 0.9997. In acidic, basic, oxidative, thermal, photolytic forced degradation conditions, the peak of degradation product was clearly and well separated from drug peak without any interference in quantitative analysis. This represents stability indicating nature of established method. Conclusion The established RP-HPLC method is simple, accurate, specific, precise, robust, rugged, sensitive, and economical in nature which can be utilized for routine analysis of mifepristone in bulk and pharmaceutical formulation.Mohammad Mojeeb Gulzar KhanMohammad Faizan Saadique DeshmukhSandip Dinkar FirkeAbdul Talib Abdul WahabMohan Ganpatrao KalaskarAtul Arun ShirkhedkarSpringerOpenarticleMifepristoneStability indicating RP-HPLC methodForced degradation studiesTherapeutics. PharmacologyRM1-950Pharmacy and materia medicaRS1-441ENFuture Journal of Pharmaceutical Sciences, Vol 7, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Mifepristone Stability indicating RP-HPLC method Forced degradation studies Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
spellingShingle	Mifepristone Stability indicating RP-HPLC method Forced degradation studies Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441 Mohammad Mojeeb Gulzar Khan Mohammad Faizan Saadique Deshmukh Sandip Dinkar Firke Abdul Talib Abdul Wahab Mohan Ganpatrao Kalaskar Atul Arun Shirkhedkar New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
description	Abstract Background Mifepristone is progestational and glucocorticoid hormone antagonist. The objective of this study is to develop simple and economical stability indicating RP-HPLC method for the determination of mifepristone in bulk and tablet formulation. Result The chromatographic separation was achieved on Qualisil BDS C8 column with mobile phase containing of mixture of Buffer (Potassium dihydrogen ortho phosphate, pH to 3.0 with ortho phosphoric acid) and Organic Solvent (Acetonitrile) 60:40 v/v pumped at flow rate 0.6 mL min−1. The detection of elute was performed using PDA detector at 305 nm. Mifepristone was eluted at 8.67 min. According to international conference on harmonization Q2(R1) guideline, method was validated and shows satisfactory results for accuracy, precision, linearity, ruggedness, robustness, detection limit, quantitation limit. The method indicated to be linear in the series of concentration 3–18 µg mL−1, and correlation coefficient was 0.9997. In acidic, basic, oxidative, thermal, photolytic forced degradation conditions, the peak of degradation product was clearly and well separated from drug peak without any interference in quantitative analysis. This represents stability indicating nature of established method. Conclusion The established RP-HPLC method is simple, accurate, specific, precise, robust, rugged, sensitive, and economical in nature which can be utilized for routine analysis of mifepristone in bulk and pharmaceutical formulation.
format	article
author	Mohammad Mojeeb Gulzar Khan Mohammad Faizan Saadique Deshmukh Sandip Dinkar Firke Abdul Talib Abdul Wahab Mohan Ganpatrao Kalaskar Atul Arun Shirkhedkar
author_facet	Mohammad Mojeeb Gulzar Khan Mohammad Faizan Saadique Deshmukh Sandip Dinkar Firke Abdul Talib Abdul Wahab Mohan Ganpatrao Kalaskar Atul Arun Shirkhedkar
author_sort	Mohammad Mojeeb Gulzar Khan
title	New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
title_short	New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
title_full	New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
title_fullStr	New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
title_full_unstemmed	New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation
title_sort	new stability indicating rp-hplc-pda method for determination of mifepristone in bulk and tablet formulation
publisher	SpringerOpen
publishDate	2021
url	https://doaj.org/article/95aae83e816140e39d43cd909b62b8d0
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New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation

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