Content of formoterol fumarate assay (%) |
Parameter |
Sample 1 |
Sample 2 |
Sample 3 |
Mean |
RSD (%) |
Flow rate (mL/min) |
0.9 |
96.5 |
98.2 |
97.2 |
97.3 |
0.88 |
1.0 |
101.2 |
99.9 |
100.2 |
100.4 |
0.68 |
1.1 |
98.7 |
99.7 |
99.8 |
99.4 |
0.61 |
Column temperature (°C) |
35°C |
94.2 |
95.8 |
95.2 |
95.1 |
0.85 |
40°C |
101.2 |
101.2 |
102.4 |
101.6 |
0.68 |
45°C |
97.0 |
98.5 |
98.0 |
97.8 |
0.78 |
Buffer pH 3.0 |
2.8 |
96.4 |
99.1 |
95.8 |
97.1 |
1.81 |
3.0 |
99.8 |
102.8 |
99.4 |
100.7 |
1.85 |
3.2 |
94.0 |
97.5 |
95.8 |
95.8 |
1.83 |
Mobile Phase composition (v/v) |
48:52 |
99.4 |
102.5 |
101.3 |
101.1 |
1.55 |
50:50 |
99.0 |
99.1 |
99.6 |
99.2 |
0.32 |
52:48 |
99.2 |
102.5 |
102.1 |
101.3 |
1.78 |
Content of mometasone furoate assay (%) |
Parameter |
Sample 1 |
Sample 2 |
Sample 3 |
Mean |
RSD (%) |
Flow rate (mL/min) |
0.9 |
102.6 |
102.4 |
101.8 |
102.3 |
0.41 |
1.0 |
103.7 |
103.1 |
103.4 |
103.4 |
0.29 |
1.1 |
100.7 |
103.0 |
104.6 |
102.8 |
1.91 |
Column temperature (°C) |
35°C |
102.8 |
102.9 |
102.4 |
102.7 |
0.26 |
40°C |
103.0 |
103.0 |
102.6 |
102.9 |
0.22 |
45°C |
101.0 |
101.2 |
100.9 |
101.0 |
0.15 |
Buffer pH 3.0 |
2.8 |
102.0 |
102.5 |
101.7 |
102.1 |
0.40 |
3.0 |
101.5 |
101.7 |
101.2 |
101.5 |
0.25 |
3.2 |
101.4 |
100.1 |
102.0 |
101.2 |
0.96 |
Mobile Phase composition (v/v) |
48:52 |
100.8 |
101.8 |
105.7 |
101.8 |
0.93 |
50:50 |
101.1 |
101.1 |
101.4 |
101.2 |
0.17 |
52:48 |
101.4 |
103.0 |
105.3 |
103.2 |
1.90 |
|