<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Wannur, Vishal Irappa</style></author><author><style face="normal" font="default" size="100%">Patil, Archana S.</style></author><author><style face="normal" font="default" size="100%">Sawadi, Bhavana</style></author><author><style face="normal" font="default" size="100%">Koli, Rahul</style></author><author><style face="normal" font="default" size="100%">Shaligram, Parth Shailendra</style></author><author><style face="normal" font="default" size="100%">shet, Nagabhushan</style></author><author><style face="normal" font="default" size="100%">Gonnade, Rajesh G.</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Quality by design-based development and validation of a stability-indicating RP-HPLC method for quantitative estimation of enzalutamide in eutectic mixtures</style></title><secondary-title><style face="normal" font="default" size="100%">SSC Plus</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2025</style></year><pub-dates><date><style  face="normal" font="default" size="100%">SEP</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">8</style></volume><pages><style face="normal" font="default" size="100%">e70119</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;
	&lt;span style=&quot;color: rgb(0, 0, 0); font-family: &amp;quot;Open Sans&amp;quot;, icomoon, sans-serif; font-size: 16px;&quot;&gt;Metastatic castration-resistant prostate cancer presents a significant clinical challenge, with Enzalutamide—an androgen receptor inhibitor—serving as a standard therapeutic agent. Despite its efficacy, poor aqueous solubility (Biopharmaceutics classification system Class II) limits its bioavailability, necessitating advanced formulation strategies. This study reports a robust and validated Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for quantifying enzalutamide in bulk and eutectic formulations. A Quality by Design framework employing a Box–Behnken design was used to optimize chromatographic parameters: 60% acetonitrile, 1&amp;nbsp;mL/min flow rate, 30°C column temperature, and 234&amp;nbsp;nm detection wavelength. The method exhibited strong linearity (2–12&amp;nbsp;µg/mL,&amp;nbsp;&lt;/span&gt;&lt;i style=&quot;box-sizing: border-box; color: rgb(0, 0, 0); font-family: &amp;quot;Open Sans&amp;quot;, icomoon, sans-serif; font-size: 16px;&quot;&gt;r&lt;/i&gt;&lt;span style=&quot;box-sizing: border-box; line-height: 0; position: relative; vertical-align: baseline; top: -0.5em; color: rgb(0, 0, 0); font-family: &amp;quot;Open Sans&amp;quot;, icomoon, sans-serif;&quot;&gt;2&lt;/span&gt;&lt;span style=&quot;color: rgb(0, 0, 0); font-family: &amp;quot;Open Sans&amp;quot;, icomoon, sans-serif; font-size: 16px;&quot;&gt;&amp;nbsp;=&amp;nbsp;0.9985) with a limit of detection and limit of quantification of 0.464 and 1.40&amp;nbsp;µg/mL, respectively. Validation per International Council for Harmonisation Q2 (R1/R2) confirmed accuracy, precision, robustness, and system suitability. Forced degradation studies verified its stability-indicating capability. Eutectic mixtures with succinic acid, caffeine, and ferulic acid were prepared via liquid-assisted grinding and characterized using powder x-ray diffraction, confirming crystalline eutectic formation. Recovery ranged from 96.7% to 99.8%, supporting the method's applicability in routine analysis and formulation development. Greenness evaluation using various tools confirmed the method's low environmental impact and high operational feasibility. This validated RP-HPLC method enables reliable quantification of enzalutamide, supporting the development of novel bioavailability-enhancing formulations for effective prostate cancer management.&lt;/span&gt;&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">9</style></issue><work-type><style face="normal" font="default" size="100%">Article</style></work-type><custom3><style face="normal" font="default" size="100%">&lt;p&gt;
	Foreign&lt;/p&gt;
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	1.6&lt;/p&gt;
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