Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Table 3
Results of accuracy/swabs of stainless steel.
Solution
Accuracy, recovery (%)
Average recovery (%)
RSD (%)
LOQ (0.155 g of ANTd/mL)
94.37 98.05 97.58
97
2.1
0.27 µg of ANTd/mL
94.75 94.42 99.94
96
3.2
19 µg of ANTd/mL
105.74 106.35 111.84
108
3.1
29 µg of ANTd/mL
103.43 107.65 100.36
104
3.5
Criterion of acceptance: average recovery
(i) LOQ concentration level: 80–120% (ii) Others: 85–115%