Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S(−)Amlodipine and S(−)Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form

<table class="table-group" id="tab9"><tr><td><table class="table"><tr><td class="thead-hr" colspan="5"><hr/></td></tr><tr class="thead"><td align="left" rowspan="2">Spiking level</td><td align="center" colspan="2">Amlodipine related compound-A</td><td align="center" colspan="2">Metoprolol Succinamide impurity</td></tr><tr class="thead"><td align="center">% mean recovery</td><td align="center">%RSD</td><td align="center">% mean recovery</td><td align="center">%RSD</td></tr><tr><td class="thead-hr" colspan="5"><hr/></td></tr><tr><td align="left">LOQ</td><td align="center">94.78</td><td align="center">1.13</td><td align="center">105.30</td><td align="center">0.33</td></tr><tr><td align="left">Level-1 (50%)</td><td align="center">92.17</td><td align="center">1.04</td><td align="center">101.71</td><td align="center">1.79</td></tr><tr><td align="left">Level-2 (100%)</td><td align="center">94.45</td><td align="center">0.73</td><td align="center">100.05</td><td align="center">1.22</td></tr><tr><td align="left">Level-3 (150%)</td><td align="center">97.31</td><td align="center">0.45</td><td align="center">101.45</td><td align="center">0.97</td></tr><tr class="table-tr"><td colspan="5"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Recovery of Amlodipine related compound-A and Metoprolol Succinamide impurity.

Chromatography Research International

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Table 9

Table 9: Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S(−)Amlodipine and S(−)Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form 

Table 9 | Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S(−)Amlodipine and S(−)Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form 