A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation
Table 7
Robustness study of NMS API.
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 API at wavelength = 215 ± 2 nm
At wavelength = 217 nm
At wavelength = 213 nm
NMS
10.387 ± 0.086
0.828
17768873 ± 106476.7
0.599
10.304 ± 0.062
0.6002
25602860 ± 50635
0.198
Impurity A
4.856 ± 0.043
0.887
39372 ± 51.08
0.130
4.861 ± 0.0257
0.5289
37201 ± 19
0.051
Impurity B
7.871 ± 0.047
0.603
3246 ± 6.81
0.210
7.872 ± 0.019
0.2431
3146 ± 9.17
0.291
Impurity C
29.622 ± 0.067
0.226
45084 ± 27.30
0.061
29.608 ± 0.068
0.2307
7475 ± 65.73
0.088
Robustness study of NMS API at flow rate = 1.0 ± 0.2 mL/min
At flow rate = 1.2 mL/min
At flow rate = 0.8 mL/min
NMS
9.097 ± 0.009
0.0939
22443297 ± 40747.54
0.182
11.92 ± 0.014
0.119
33639814 ± 79924.44
0.238
Impurity A
4.071 ± 0.027
0.6542
40086 ± 55.08
0.137
6.038 ± 0.023
0.379
58861 ± 45.09
0.077
Impurity B
7.318 ± 0.060
0.8136
2072 ± 9.29
0.448
9.621 ± 0.040
0.416
4708 ± 20.07
0.426
Impurity C
27.016 ± 0.001
0.0037
55508 ± 66.16
0.119
33.659 ± 0.049
0.145
81426 ± 41.19
0.051
Robustness study of NMS API for mobile phase A (phosphate buffer) pH = 3.0 ± 0.1
