Development and Validation of Stability Indicating LC-PDA Method for Mycophenolate Mofetil in Presence of Mycophenolic Acid and Its Application for Degradation Kinetics and pH Profile Study
Table 2
Results of method sensitivity, linearity, precision, system suitability, and recovery of analytes.
Parameter/analytes ()
MPA (5.9)
MMF (6.8)
DP3 (7.9)
Method sensitivity
Limit of detection (LOD, g/mL)
0.026
0.121
0.02
Limit of detection (LOQ, g/mL)
0.078
0.366
0.06
Concentration range (g/mL)
0.08–16
0.4–120
0.06–12
Regression equation () data
Intercept ()
1975.0
−2289.8
−2253.7
Slope ()
70583.2
44428.2
86070.0
(error in intercept)
4786 ± 9299.2
6789.6 ± 12628.6
1731.9 ± 3281.9
(error in slope )
734 ± 1426.3
118.3 ± 286.4
286.4 ± 542.8
Correlation coefficient ()
0.999
0.999
0.999
Precision data, % RSD
Repeatability,
0.29
0.15
0.34
Intraday precision, times
0.4
0.35
0.43
Interday precision, days
0.45
0.42
0.52
System suitability data (USP-NF 29 section 621, pp. 2135)
Number of theoretical plates (±SD)
3450 ± 32
4255 ± 26
3865 ± 50
USP tailing factor (±SD)
1.01 ± 0.01
1.01 ± 0.01
1.00 ± 0.042
USP resolution
5.9c
2.2
2.25
Recovery study at the level (% recovery, % RSD),
50%,
99.35, 0.77
101.6, 0.59
99.56, 1.23
100%
100.5, 0.73
100.3, 0.45
98.87, 0.76
150%
100.8, 0.89
99.98, 0.34
100.2, 0.91
= 1.86, 1.895, 1.943 for MMF, DP1, and MPA, respectively (; df = 8), astandard deviation (SD) of intercept, bSD of slope, and cresolution with respect to IS HTZ peak.
