Tab. 2.
Relative Retention time (RRT), Limit of Quantification (LOQ), Relative response factor (RRF) and Recovery data of the Docetaxel and its Impurities.
Name of the Impurity | ∼RRT | K1 | LOD (in %) | LOQ (in %) | RRF | % RSD at LOQa | %Recovery at LOQb |
---|---|---|---|---|---|---|---|
10-Deacetylbaccatin III | 0.11 | 4.2 | 0.002 | 0.006 | 1.53 | 2.1 | 99.0 |
7-Epi-10-deacetyl-baccatin III | 0.20 | 8.3 | NA | NA | NA | NA | NA |
7-Epi-10-oxo-10-deacetylbaccatin III | 0.22 | 9.2 | NA | NA | NA | NA | NA |
2′,3′-Epidocetaxel | 0.88 | 39.9 | 0.003 | 0.008 | 0.96 | 1.9 | 106.4 |
2′-Epidocetaxel | 0.94 | 42.7 | 0.003 | 0.009 | 1.02 | 3.4 | 96.4 |
Oxetane ring opened impurity of Docetaxel | 0.97 | 44.1 | 0.004 | 0.011 | 0.73 | 2.5 | 94.7 |
Docetaxel | 1.00 | 45.4 | 0.003 | 0.008 | 1.00 | 1.5 | 100.6 |
10-Oxodocetaxel | 1.05 | 47.8 | 0.003 | 0.014 | 0.91 | 3.7 | 108.3 |
7′-Epidocetaxel | 1.11 | 50.6 | 0.003 | 0.011 | 1.00 | 2.4 | 96.1 |
10-Oxo-7′epidocetaxel | 1.14 | 52.0 | 0.002 | 0.006 | 1.35 | 2.6 | 97.1 |
NE = Not Established due to non-availability of impurity standards; NA= Not applicable;
Mean for six determinations;
Mean for three determinations