| Parameter |
Acceptance criteria |
Results |
| System Suitability |
% RSD Not More Than 15.0% |
1.6% to 8.1% |
| Precision |
% RSD (six sample preparation) Not More Than 15.0% |
@ LOQ level – 7.7 to 12.2% and 100% Level 3.2 to 7.6% |
| Linearity |
Correlation coefficient Not Less Than 0.995 |
0.997 to 0.998 |
| Accuracy |
Percent Recovery 85.0% to 115.0% |
90.0 to 107.0%
[Overall recovery form LOQ to 150%] |
| Robustness and Ruggedness |
% RSD Not More Than 15.0% |
4.1 to 8.1%
[Overall compilation of system suitability] |
