Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms
Table 7
LOD, LOQ, linearity, relative response factor, and precision data.
Parameter
EFX at 278 nm
EFX at 254 nm
%Decarboxylated impurity
%FQ Acid impurity
%ED impurity
%Desfluoro impurity
%Cipro base impurity
%Chloro impurity
LOD (μg mL−1)
0.106
0.266
0.105
0.100
0.099
0.103
0.106
0.106
ratio
4
6
5
5
6
6
4
5
LOQ (μg mL−1)
0.266
0.532
0.261
0.249
0.248
0.258
0.266
0.265
ratio
13
17
15
17
19
18
14
15
Relative response factor
—
—
0.46
0.32
0.87
0.83
0.92
1.09
Method precision (% RSD)a
—
—
1.5%
1.6%
0.9%
1.8%
1.7%
1.9%
Intermediate precision (% RSD)b
—
—
1.8%
1.7%
1.3%
1.2%
1.6%
1.5%
Regression statistics
Slope
71160
17902
39100
56718
82107
85531
77739
65090
Intercept
−481.8
−216.8
−1336.5
−1150.4
−445.7
−2163.6
−1660.2
2529.3
Coefficient of determination ()
0.9937
0.9920
0.9966
0.9986
0.9888
0.9930
0.9990
0.9905
Intercept at 95% confidence interval (lower value–upper value)
6255.01–5291.4
1849.7–1416.1
3577.4–904.5
3336.2–1035.5
8949.5–8058.1
9364.1–5036.9
3963.5–643.1
3828.3–8886.8
Slope at 95% confidence interval (lower value–upper value)
64629.7–77689.3
16054.9–19748.9
36511.0–41687.9
54278.1–59158.2
72068.0–92146.6
77286.7–93775.9
75035.1–80443.2
57779.0–72400.9
Method precision calculated from six preparations of impurities spiked solutions.
bIntermediate precision calculated from six preparations of impurities spiked solutions.