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1. Verfasser: Pandey Shivangi1, Dr. Bhumi R. Patel2*, Mr. Jaymin G. Patel2, Ms. Pooja Soni3, Mr. Ronak N. Patel4, Dr. Divyakant A. Patel5
Format: Recurso digital
Sprache:Englisch
Veröffentlicht: Zenodo 2026
Online-Zugang:https://doi.org/10.5281/zenodo.19876912
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  • <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>