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Table 2 Robustness of the method for doxorubicin (DOX)

From: Enhancement of oral bioavailability of doxorubicin through surface modified biodegradable polymeric nanoparticles

(a) Robustness
Conditions LQC (2.90 ng/ml) MQC(1000 ng/ml) HQC (2000 ng/ml)
Mobile phase [ACN: 0.1% formic acid (50:50: v/v)]
 Negative level (49.9:50.10, n = 3) 2.70 ± 0.11 (4.07%) 970.10 ± 11.01 (1.13%) 1967.89 ± 15.09 (0.77%)
 Zero level (50:50, n = 3) 2.84 ± 0.02 (0.70%) 981.89 ± 13.99 (1.42%) 1988.99 ± 11.89 (0.60%)
 Positive level (50.10:49.90, n = 3) 2.75 ± 0.12 (4.36%) 974.91 ± 12.08 (1.24%) 1970.01 ± 14.09 (0.72%)
Flow rate (0.20 ml/min)
 Negative level (0.19, n = 3) 2.61 ± 0.09 (3.45%) 969.01 ± 11.33 (1.17%) 1971.61 ± 19.02 (0.96%)
 Zero level (0.20, n = 3) 2.79 ± 0.081 (2.90%) 988.78 ± 12.01 (1.21%) 1981.01 ± 12.91 (0.65%)
 Positive level (0.21, n = 3) 2.70 ± 0.12 (4.44%) 972.05 ± 10.56 (1.09%) 1967.29 ± 11.56 (0.59%)
pH of mobile phase (default pH = 7.2)
 Negative level (6.9, n = 3) 2.61 ± 0.061 (2.34%) 971.98 ± 5.99 (0.62%) 1968.45 ± 11.05 (0.56%)
 Zero level (7.2, n = 3) 2.84 ± 0.012 (0.42%) 985.11 ± 8.92 (0.91%) 1985.42 ± 10.66 (0.54%)
 Positive level (7.4, n = 3) 2.69 ± 0.058 (2.16%) 974.91 ± 6.30 (0.65%) 1977.00 ± 15.99 (0.81%)
  1. Values (Mean ± SD) are derived from 6 replicates:
  2. a Accuracy (%) = Mean value of [(mean observed concentration)/(theoretical concentration)] × 100
  3. b Precision (%): coefficient of variance (percentage) = standard deviation divided by mean concentration found × 100; Theoretical contents; LOQQC: 1.01 ng/ml, LQC: 2.90 ng/ml; MQC: 1000 ng/ml; and HQC: 2000 ng/ml
(b) Ruggedness
QC ID Theoretical content (ng/ml) Mean concentration observed (ng/ml) Accuracy a (%) CV (%) b
LOQQC 1.01 0.95 ± 0.021 94.60 2.21
LQC 2.90 2.81 ± 0.088 96.90 3.13
MQC 1000.00 981.01 ± 9.33 98.10 0.95
HQC 2000.00 1979.01 ± 5.00 98.95 0.25
  1. Values (Mean ± SD) are derived from 6 replicates:
  2. a Accuracy (%) = Mean value of [(mean observed concentration)/(theoretical concentration)] × 100
  3. b Precision (%): coefficient of variance (percentage) = standard deviation divided by mean concentration found × 100; Theoretical contents; LOQQC: 1.01 ng/ml, LQC: 2.90 ng/ml; MQC: 1000 ng/ml; and HQC: 2000 ng/ml