Tab. 3.
Results of recovery study:
Name of the impurity | Amount spikeda | % Recoveryb | ||||
---|---|---|---|---|---|---|
50% | 100% | 150% | 50% | 100% | 150% | |
10-Deacetylbaccatin III | 0.15 | 0.3 | 0.45 | 99.1 | 100.2 | 99.3 |
2′,3′-Epidocetaxel | 0.15 | 0.3 | 0.45 | 100.1 | 100.5 | 99.4 |
2′-Epidocetaxel | 0.15 | 0.3 | 0.45 | 98.2 | 99.5 | 98.2 |
Oxetane ring opened impurity of Docetaxel | 0.15 | 0.3 | 0.45 | 97.8 | 98.2 | 97.5 |
10-Oxodocetaxel | 0.15 | 0.3 | 0.45 | 99.6 | 99.7 | 96.7 |
7′-Epidocetaxel | 0.15 | 0.3 | 0.45 | 96.4 | 95.7 | 97.5 |
10-Oxo-7′-epidocetaxel | 0.15 | 0.3 | 0.45 | 98.9 | 97.2 | 96.5 |
Amount of impurities spiked with respect to 0.30% specification level individually to 0.8 mg/ml of docetaxel;
Mean±%RSD for three determinations.