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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ANALYTICAL METHOD FOR ESTIMATION OF ACEBROPHYLLINE AND ERDOSTEINE IN SYNTHETIC MIXTURE

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Autor principal:	Pandey Shivangi1, Dr. Bhumi R. Patel2*, Mr. Jaymin G. Patel2, Ms. Pooja Soni3, Mr. Ronak N. Patel4, Dr. Divyakant A. Patel5
Formato:	Recurso digital
Lenguaje:	inglés
Publicado:	Zenodo 2026
Acceso en línea:	Acceder al recurso
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_version_	1866901867822317568
author	Pandey Shivangi1, Dr. Bhumi R. Patel2*, Mr. Jaymin G. Patel2, Ms. Pooja Soni3, Mr. Ronak N. Patel4, Dr. Divyakant A. Patel5
author_facet	Pandey Shivangi1, Dr. Bhumi R. Patel2*, Mr. Jaymin G. Patel2, Ms. Pooja Soni3, Mr. Ronak N. Patel4, Dr. Divyakant A. Patel5
contents	<p><span>A<span> </span>simple,<span> </span>precise,<span> </span>and<span> </span>accurate<span> </span>stability<span> </span>indicating<span> </span>RP-HPLC<span> </span>method<span> </span>was<span> </span>developed for the estimation of Acebrophylline and Erdosteine in synthetic mixture. The quantification<span> </span>was<span> </span>carried<span> </span>out<span> </span>using<span> </span>Zorbax<span> </span>C18<span> </span>column<span> </span>(250<span> </span>mm<span> </span>x<span> </span>4.6<span> </span>mm<span> </span>x<span> </span>5<span> </span>µm) and mobile phase comprised of 0.1 % Formic acid: Phosphate Buffer pH 4.8: Methanol in proportion of 60:15:25% v/v. The Flow rate was adjusted to 1.0 mL/min and the effluent was monitored at 220 nm using PDA detector. The retention time of Acebrophylline and Erdosteine was found to be 19.807 min 8.907 min respectively. The methods were validated in terms of specificity, linearity, precision, and accuracy, limit of detection, limit of quantification and robustness. <span>The</span><span> </span><span>percentage</span><span> </span><span>assay</span><span> </span><span>was</span><span> </span><span>found</span><span> </span><span>to</span><span> </span><span>be</span><span> </span><span>100.206</span><span> </span><span>%</span><span> </span><span>for</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>100.154</span><span> </span><span>%</span><span> </span><span>for </span><span>Erdosteine</span><span> </span><span>in</span><span> </span><span>RP-HPLC method. Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine were</span> <span>subjected</span> <span>to</span> <span>stress </span>condition like<span> </span>Acid,<span> </span>Base, Oxidative,<span> </span>Thermal &<span> </span>Photo condition. Acceptable<span> </span>range <span>of <span>degradation</span><span> </span><span>was observed in</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>in all the condition. The </span>degradation products were well resolved from the pure drug with significant differences in their retention time. Thus, the proposed method enables rapid <span>quantification</span><span> </span><span>and</span><span> </span><span>simultaneous</span> <span>estimation</span><span> </span><span>of</span><span> </span><span>the</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>drug without</span><span> </span><span>any</span><span> </span><span>interference</span><span> </span><span>of</span><span> </span><span>excipients.</span><span> </span><span>So,</span><span> </span><span>the</span><span> </span><span>developed</span><span> </span><span>and</span><span> </span><span>validated</span><span> </span><span>method</span><span> </span><span>can</span><span> </span><span>be used</span><span> </span><span>for</span> <span>routine</span><span> </span><span>analysis</span><span> </span><span>of</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>in</span> <span>synthetic</span><span> </span><span>mixture.</span></span></span></p>
format	Recurso digital
id	zenodo_https___doi_org_10_5281_zenodo_19876912
institution	Zenodo
language	eng
publishDate	2026
publisher	Zenodo
record_format	zenodo
spellingShingle	DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ANALYTICAL METHOD FOR ESTIMATION OF ACEBROPHYLLINE AND ERDOSTEINE IN SYNTHETIC MIXTURE Pandey Shivangi1, Dr. Bhumi R. Patel2*, Mr. Jaymin G. Patel2, Ms. Pooja Soni3, Mr. Ronak N. Patel4, Dr. Divyakant A. Patel5 <p><span>A<span> </span>simple,<span> </span>precise,<span> </span>and<span> </span>accurate<span> </span>stability<span> </span>indicating<span> </span>RP-HPLC<span> </span>method<span> </span>was<span> </span>developed for the estimation of Acebrophylline and Erdosteine in synthetic mixture. The quantification<span> </span>was<span> </span>carried<span> </span>out<span> </span>using<span> </span>Zorbax<span> </span>C18<span> </span>column<span> </span>(250<span> </span>mm<span> </span>x<span> </span>4.6<span> </span>mm<span> </span>x<span> </span>5<span> </span>µm) and mobile phase comprised of 0.1 % Formic acid: Phosphate Buffer pH 4.8: Methanol in proportion of 60:15:25% v/v. The Flow rate was adjusted to 1.0 mL/min and the effluent was monitored at 220 nm using PDA detector. The retention time of Acebrophylline and Erdosteine was found to be 19.807 min 8.907 min respectively. The methods were validated in terms of specificity, linearity, precision, and accuracy, limit of detection, limit of quantification and robustness. <span>The</span><span> </span><span>percentage</span><span> </span><span>assay</span><span> </span><span>was</span><span> </span><span>found</span><span> </span><span>to</span><span> </span><span>be</span><span> </span><span>100.206</span><span> </span><span>%</span><span> </span><span>for</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>100.154</span><span> </span><span>%</span><span> </span><span>for </span><span>Erdosteine</span><span> </span><span>in</span><span> </span><span>RP-HPLC method. Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine were</span> <span>subjected</span> <span>to</span> <span>stress </span>condition like<span> </span>Acid,<span> </span>Base, Oxidative,<span> </span>Thermal &<span> </span>Photo condition. Acceptable<span> </span>range <span>of <span>degradation</span><span> </span><span>was observed in</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>in all the condition. The </span>degradation products were well resolved from the pure drug with significant differences in their retention time. Thus, the proposed method enables rapid <span>quantification</span><span> </span><span>and</span><span> </span><span>simultaneous</span> <span>estimation</span><span> </span><span>of</span><span> </span><span>the</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>drug without</span><span> </span><span>any</span><span> </span><span>interference</span><span> </span><span>of</span><span> </span><span>excipients.</span><span> </span><span>So,</span><span> </span><span>the</span><span> </span><span>developed</span><span> </span><span>and</span><span> </span><span>validated</span><span> </span><span>method</span><span> </span><span>can</span><span> </span><span>be used</span><span> </span><span>for</span> <span>routine</span><span> </span><span>analysis</span><span> </span><span>of</span><span> </span><span>Acebrophylline</span><span> </span><span>and</span><span> </span><span>Erdosteine</span><span> </span><span>in</span> <span>synthetic</span><span> </span><span>mixture.</span></span></span></p>
title	DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ANALYTICAL METHOD FOR ESTIMATION OF ACEBROPHYLLINE AND ERDOSTEINE IN SYNTHETIC MIXTURE
url	https://doi.org/10.5281/zenodo.19876912