Page 63 - Quality control of pharmaceuticals (07-PA 704)

Acceptance criteria:
• In general, there exists no specific criteria for what value LOD and LOQ must
have.
• In routine application, it has been recommended that LOQ be within the
working linear range.

7. ROBUSTNESS

It is a measure of the capacity of the analytical procedure to remain unaffected by
small but deliberate variations in some parameters and provide an indication of its
reliability during normally usage.
The robustness of the method is investigated by varying some or all conditions:

• For chromatographic analysis:
1. Organic composition of the mobile phase
2. pH
3. column temperature
4. type and age of column
5. flow rate
6. detection wavelength

• For spectrophotometric analysis;
1. Solven composition
2. pH of the solven 1
3. Concentration of reagents used in analysis
4. Temperature of the reaction
5. Time of the reaction
6. Detection wavelength