Stability-Indicating Validated Novel RP-HPLC Method for Simultaneous Estimation of Methylparaben, Ketoconazole, and Mometasone Furoate in Topical Pharmaceutical Dosage Formulation
Table 1
System suitability results (precision, intermediate precision, and robustness) for MP, KT, and MF.
Parameters
MP
KT
MF
>3000
≤2.0
≤2.0
>3000
≤2.0
≤2.0
>3000
≤2.0
≤2.0
%*
RT
%*
RT
%*
RT
Precision
4190
1.1
0.27
2.301
4270
1.0
0.17
3.095
5472
1.0
0.44
4.665
Interprecision
4452
1.1
0.22
2.306
4268
1.1
0.27
3.101
5476
1.0
0.33
4.674
1.7 mL/min flow rate
3881
1.1
0.29
2.040
3781
1.1
0.14
2.733
5007
1.0
0.83
4.137
1.3 mL/min flow rate
4923
1.1
0.22
2.637
4812
1.1
0.19
3.541
6149
1.0
0.32
5.322
55°C column temp.
4455
1.1
0.24
2.278
4365
1.1
0.31
3.058
5607
1.0
0.25
4.486
45°C column temp.
4514
1.1
0.39
2.341
4199
1.1
0.25
3.135
5580
1.0
0.61
4.844
Mobile phase pH 6.7
4289
1.1
0.29
2.302
4271
1.1
0.07
3.095
5548
1.0
1.01
4.659
Mobile phase pH 6.3
4316
1.1
0.17
2.303
4261
1.1
0.16
3.086
5565
1.0
0.56
4.644
+3.5% Acetonitrile
4422
1.1
0.35
2.271
4170
1.1
0.33
2.940
5480
1.0
1.02
4.282
−3.5% Acetonitrile
4323
1.1
0.59
2.368
4497
1.0
0.17
3.345
5641
1.0
0.69
5.242
: plate count, : tailing factor, : relative standard deviation, RT: retention time, *determined on five values.
