Table 6 The results of robustness study of IMG assay and dissolution.
Method | Condition | Conc. taken (µg. mL− 1) | T | N | Mean** % recovery | SD | RSD (%) | Pooled RSD (%) |
|---|---|---|---|---|---|---|---|---|
Flow rate (mL. min− 1) | ||||||||
Assay | 0.95 1.00* 1.05 | 40.0 | 0.9734 0.9762 0.9798 | 5826 5686 5488 | 98.81 99.77 98.68 | 0.43 0.78 0.45 | 0.435 0.784 0.453 | 0.72 |
Dissolution | 0.95 1.00* 1.05 | 40.0 | 0.948 0.956 0.951 | 5234 5440 5185 | 99.26 99.28 99.00 | 0.123 0.096 0.047 | 0.124 0.097 0.047 | 0.16 |
Column temperature (̊C) | ||||||||
Assay | 38 40* 42 | 40.0 | 0.9718 0.9732 0.9741 | 5552 5686 5466 | 99.38 99.77 98.90 | 0.402 0.782 0.449 | 0.405 0.784 0.454 | 0.63 |
Dissolution | 38 40* 42 | 40.0 | 0.954 0.956 0.932 | 5466 5440 5033 | 99.20 99.28 98.92 | 0.142 0.096 0.112 | 0.143 0.097 0.113 | 0.19 |