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. 2010 Mar 5;78(2):215–231. doi: 10.3797/scipharm.0912-14

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;

a

Mean for six determinations;

b

Mean for three determinations