A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation
Table 8
Robustness study of NMS Injection.
Component
Mean RT (min) ± SD
(%) RSD of RT
Mean of peak area ±SD
(%) RSD of peak area
Mean RT (min) ± SD
(%) RSD of RT
Mean of peak area ± SD
(%) RSD of peak area
Robustness study of NMS injection at wavelength = 215 ± 2 nm
At wavelength = 217 nm
At wavelength = 213 nm
NMS
10.384 ± 0.024
0.230
17774517 ± 22268.68
0.130
10.416 ± 0.011
0.100
25738094 ± 48861.32
0.190
Impurity A
4.889 ± 0.014
0.277
38521 ± 66.55
0.173
4.880 ± 0.025
0.104
37613 ± 61.20
0.163
Impurity B
7.881 ± 0.006
0.071
3133 ± 11.24
0.359
7.847 ± 0.034
0.428
2677 ± 23.09
0.863
Impurity C
29.605 ± 0.016
0.065
47303 ± 14.01
0.030
29.615 ± 0.008
0.025
75631 ± 149.721
0.198
Robustness study of NMS injection at flow rate = 1.0 ± 0.2 mL/min
At flow rate = 1.2 mL/min
At flow rate = 0.8 mL/min
NMS
9.082 ± 0.023
0.255
22451115 ± 38468.14
0.171
11.954 ± 0.034
0.281
33595014 ± 216906
0.646
Impurity A
4.041 ± 0.042
1.039
40158 ± 75.35
0.188
6.052 ± 0.040
0.165
58851 ± 64.29
0.109
Impurity B
7.347 ± 0.047
0.642
2052.33 ± 12.50
0.609
9.646 ± 0.023
0.247
4702 ± 23.46
0.499
Impurity C
27.09 ± 0.027
0.100
55498 ± 90.59
0.163
33.645 ± 0.046
0.136
81454 ± 46.11
0.057
Robustness study of NMS injection at mobile phase pH = 3.0 ± 0.1
