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="tab5"><tr><td><table class="table"><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr class="thead"><td align="left">Analyte</td><td align="center">LOD</td><td align="center">LOQ</td></tr><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr><td align="left">S(−)Metoprolol</td><td align="center">0.013% (0.130 ppm)</td><td align="center">0.040% (0.400 ppm)</td></tr><tr><td align="left">S(−)Amlodipine</td><td align="center">0.013% (0.026 ppm)</td><td align="center">0.040% (0.080 ppm)</td></tr><tr><td align="left">Metoprolol Succinamide impurity</td><td align="center">0.033% (0.330 ppm)</td><td align="center">0.100% (1.000 ppm)</td></tr><tr><td align="left">Amlodipine related compound-A</td><td align="center">0.066% (0.132 ppm)</td><td align="center">0.200% (0.4000 ppm)</td></tr><tr class="table-tr"><td colspan="3"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Limit of detection and limit of quantification.

Chromatography Research International

tab5

Table 5

Table 5: 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 5 | 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 