| Moxifloxacin Analytical Method Validation-Assay |
| Method Parameter |
Robustness |
| Change in Flow Rate(0.25mL/min) |
Change in Flow Rate(0.35mL/min) |
| Std. No. |
Standards |
USP
Tailing |
Std. No. |
Standards |
USP
Tailing |
| 1 |
2743760 |
1.55 |
1 |
1973875 |
1.49 |
| 2 |
2774673 |
1.55 |
2 |
1943344 |
1.49 |
| 3 |
2740829 |
1.55 |
3 |
1960245 |
1.49 |
| 4 |
2732432 |
1.55 |
4 |
1952056 |
1.49 |
| 5 |
2734277 |
1.55 |
5 |
1958542 |
1.49 |
| Average |
2745194 |
1.55 |
Average |
1957612 |
1.49 |
| STDEV |
17118.49 |
0.00 |
STDEV |
11255.31 |
0.00 |
| %RSD |
0.62 |
0.0 |
%RSD |
0.57 |
0.0 |
| |
| Change in pH of Mobile Phase(1.6) |
Change in pH of Mobile Phase(2.0) |
| Std. No. |
Standards |
USP
Tailing |
Std. No. |
Standards |
USP
Tailing |
| 1 |
2271424 |
1.49 |
1 |
2263481 |
1.53 |
| 2 |
2252217 |
1.49 |
2 |
2258739 |
1.53 |
| 3 |
2249439 |
1.49 |
3 |
2276006 |
1.53 |
| 4 |
2244184 |
1.49 |
4 |
2272593 |
1.53 |
| 5 |
2241573 |
1.48 |
5 |
2276184 |
1.53 |
| Average |
2251767 |
1.49 |
Average |
2269401 |
1.53 |
| STDEV |
11762.64 |
0.00 |
STDEV |
7882.71 |
0.00 |
| %RSD |
0.52 |
0.3 |
%RSD |
0.35 |
0.0 |
| |
|
|
|
|
|
| Change in Org Phase Composition (90%) |
Change in Org Phase Composition (110%) |
| Std. No. |
Standards |
USP
Tailing |
Std. No. |
Standards |
USP
Tailing |
| 1 |
2311223 |
1.43 |
1 |
2265737 |
1.53 |
| 2 |
2313683 |
1.43 |
2 |
2269570 |
1.53 |
| 3 |
2305552 |
1.43 |
3 |
2290266 |
1.53 |
| 4 |
2315524 |
1.43 |
4 |
2291368 |
1.53 |
| 5 |
2306395 |
1.43 |
5 |
2290691 |
1.53 |
| Average |
2310475 |
1.43 |
Average |
2281526 |
1.53 |
| STDEV |
4393.90 |
0.00 |
STDEV |
12742.53 |
0.00 |
| %RSD |
0.19 |
0.0 |
%RSD |
0.56 |
0.00 |
