A Validated New Gradient Stability-Indicating LC Method for the Analysis of Doripenem in Bulk and Injection Formulation

<table class="table-group" id="tab3"><tr><td><table class="table"><tr><td class="thead-hr" colspan="7"><hr/></td></tr><tr class="thead"><td align="center" colspan="7">Stability of standard</td></tr><tr class="thead"><td align="center" colspan="2">Initial</td><td align="center" colspan="2">1 day</td><td align="center" colspan="2">2 day</td><td align="left">Acceptance criteria</td></tr><tr><td class="thead-hr" colspan="7"><hr/></td></tr><tr><td align="left">% Assay</td><td align="center">% Diff</td><td align="center">% Assay</td><td align="center">% Diff</td><td align="center">% Assay</td><td align="center">% Diff </td><td align="left">Difference in % assay for standard</td></tr><tr><td align="left">95.3*</td><td align="center">NA</td><td align="center">91.0</td><td align="center">4.3</td><td align="center">NA</td><td align="center">NA</td><td align="left">Solution with respect to initial shall be ±3.0</td></tr><tr class="table-tr"><td colspan="7"><hr class="tbody-hr"/></td></tr></table></td></tr><tr class="table-fn"><td><svg height="13.75" id="M6" style="vertical-align:-0.0pt" version="1.1" viewbox="0 0 7.7375002 13.75" width="7.7375002" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">
<g transform="matrix(.012,-0,0,-.012,.062,5.525)"><path d="M471 153q-22 -15 -61 -13q-25 31 -45.5 49.5t-56.5 41.5q4 -71 28 -134q-17 -33 -42 -46q-24 12 -42 46q24 63 28 134q-36 -23 -56.5 -41.5t-45.5 -49.5q-36 -2 -61 13q0 28 19 59q65 10 130 43q-65 33 -130 43q-19 31 -19 59q22 15 61 13q25 -31 45.5 -49.5t56.5 -41.5
q-4 71 -28 134q17 33 42 46q24 -12 42 -46q-24 -63 -28 -134q36 23 56.5 41.5t45.5 49.5q36 2 61 -13q0 -28 -19 -59q-65 -10 -130 -43q65 -33 130 -43q19 -31 19 -59z" id="x2217"></path></g>
</svg>Potency of working standard as doripenem.<br/>NA: not applicable.<br/></td></tr></table>

Bench top stability of standard solution of doripenem.

Chromatography Research International

tab3

Table 3

Table 3: A Validated New Gradient Stability-Indicating LC Method for the Analysis of Doripenem in Bulk and Injection Formulation 