Stability Study of Darunavir Ethanolate Tablets Applying a New Stability-Indicating HPLC Method

<table class="table-group" id="tab1"><tr><td><table class="table"><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr class="thead"><td align="left">Chromatographic parameters</td><td align="center">Results</td><td align="center">Acceptance criteria</td></tr><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr><td align="left"><svg height="14.3625" id="M2" style="vertical-align:-3.3525pt" version="1.1" viewbox="0 0 14.2125 14.3625" width="14.2125" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
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<g transform="matrix(.012,-0,0,-.012,5.862,14.2)"><path d="M627 18l-10 -26q-79 6 -116 27t-69 76q-41 71 -71 138q-13 29 -27.5 39t-42.5 10h-46l-27 -145q-13 -74 -2.5 -88.5t78.5 -20.5l-6 -28h-271l5 28q66 6 82.5 21.5t30.5 87.5l71 387q12 66 2 78.5t-77 19.5l8 28h233q102 0 147 -29q65 -43 65 -129q0 -69 -45.5 -117
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</svg> (retention time, min)</td><td align="center">7.4</td><td align="center">—</td></tr><tr><td align="left"><svg height="15.8375" id="M3" style="vertical-align:-3.3907pt" version="1.1" viewbox="0 0 17.775 15.8375" width="17.775" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,11.55)"><path d="M649 676l-22 -187l-33 -2q3 56 -12 94q-8 20 -31.5 26.5t-86.5 6.5h-74l-90 -491q-4 -23 -6 -36.5t1 -25t7 -16.5t18 -9t27 -5t41 -3l-6 -28h-286l4 28q68 5 84 18.5t28 76.5l94 491h-55q-74 0 -100.5 -6t-41.5 -23q-24 -29 -54 -98l-32 1q32 98 53 188h22q7 -18 15 -22
t37 -4h417q23 0 33.5 5t25.5 21h23z" id="x1D447"></path></g>
<g transform="matrix(.012,-0,0,-.012,11.388,15.637)"><path d="M241 635q53 0 94 -28.5t63.5 -76t33.5 -102.5t11 -116q0 -58 -11 -112.5t-34 -103.5t-63.5 -78.5t-94.5 -29.5t-95 28t-64.5 75t-34.5 102.5t-11 118.5q0 58 11.5 112.5t34.5 103t64.5 78t95.5 29.5zM238 602q-32 0 -55.5 -25t-35.5 -68t-17.5 -91t-5.5 -105
q0 -76 10 -138.5t37 -107.5t69 -45q32 0 55.5 25t35.5 68.5t17.5 91.5t5.5 105t-5.5 105.5t-18 92t-36 68t-56.5 24.5z" id="x30"></path></g>
</svg> (column dead time, min)</td><td align="center">1.2</td><td align="center">—</td></tr><tr><td align="left"><svg height="17.9125" id="M4" style="vertical-align:-0.1638pt" version="1.1" viewbox="0 0 12.8375 17.9125" width="12.8375" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,17.65)"><path d="M480 416q0 -21 -18 -41q-9 -11 -17 -7q-20 9 -42 9q-62 0 -140 -78q23 -69 88 -192q17 -31 27 -42t20 -11q16 0 62 46l17 -20q-64 -92 -119 -92q-35 0 -70 66q-41 73 -84 187q-36 -30 -62 -61q-27 -115 -35 -172q-41 -8 -78 -20l-6 6l140 612q7 28 0.5 34t-37.5 7l-34 1
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<g transform="matrix(.012,-0,0,-.012,8.612,9.488)"><path d="M227 744l-123 -338l-31 15l73 368q12 3 41.5 -8t36.5 -20z" id="x2032"></path></g>
</svg> (retention factor)</td><td align="center">5.16</td><td align="center">2 &lt; <svg height="17.9125" id="M5" style="vertical-align:-0.1638pt" version="1.1" viewbox="0 0 12.8375 17.9125" width="12.8375" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,17.65)"><path d="M480 416q0 -21 -18 -41q-9 -11 -17 -7q-20 9 -42 9q-62 0 -140 -78q23 -69 88 -192q17 -31 27 -42t20 -11q16 0 62 46l17 -20q-64 -92 -119 -92q-35 0 -70 66q-41 73 -84 187q-36 -30 -62 -61q-27 -115 -35 -172q-41 -8 -78 -20l-6 6l140 612q7 28 0.5 34t-37.5 7l-34 1
l5 26q38 4 74 13.5t57 17t25 7.5q12 0 4 -32l-104 -443h2q35 38 97 93q39 35 65.5 56t62 41.5t58.5 20.5q19 0 30.5 -10t11.5 -22z" id="x1D458"></path></g>
<g transform="matrix(.012,-0,0,-.012,8.612,9.488)"><path d="M227 744l-123 -338l-31 15l73 368q12 3 41.5 -8t36.5 -20z" id="x2032"></path></g>
</svg> &lt; 10</td></tr><tr><td align="left"><svg height="11.3125" id="M6" style="vertical-align:-0.1092pt" version="1.1" viewbox="0 0 14.9875 11.3125" width="14.9875" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,11.113)"><path d="M857 650l-6 -28q-44 -4 -61.5 -16.5t-29.5 -48.5q-11 -32 -37 -166l-78 -399h-29l-351 537h-4l-56 -276q-24 -120 -24 -164q0 -35 17.5 -46t75.5 -15l-6 -28h-245l7 28q41 2 62 14t31 44q10 30 41 171l53 245q8 44 6.5 60.5t-14.5 33.5q-10 15 -27 19.5t-64 6.5l6 28h153
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</svg> (column efficiency)</td><td align="center">2433</td><td align="center"><svg height="11.3125" id="M7" style="vertical-align:-0.1092pt" version="1.1" viewbox="0 0 14.9875 11.3125" width="14.9875" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.017,-0,0,-.017,.062,11.113)"><path d="M857 650l-6 -28q-44 -4 -61.5 -16.5t-29.5 -48.5q-11 -32 -37 -166l-78 -399h-29l-351 537h-4l-56 -276q-24 -120 -24 -164q0 -35 17.5 -46t75.5 -15l-6 -28h-245l7 28q41 2 62 14t31 44q10 30 41 171l53 245q8 44 6.5 60.5t-14.5 33.5q-10 15 -27 19.5t-64 6.5l6 28h153
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</svg> &gt; 2000</td></tr><tr class="table-tr"><td colspan="3"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Chromatographic parameters and the acceptance criteria for darunavir determination by developed LC method.

Chromatography Research International

tab1

Table 1

Table 1: Stability Study of Darunavir Ethanolate Tablets Applying a New Stability-Indicating HPLC Method 