Using validated methods is a must for pharmaceutical assay determination to comply with regulatory requirements. A free white paper gives guidance and defines a procedure how to perform a proper validation of titration methods. The procedure follows ICH Guidance Q2(R1) and USP General Chapter <1225> and is exemplified using the determination of potassium bicarbonate sample as an example.
Method validation of a titration ensures that the selected titration method and parameters provide a reliable and robust result. The procedure outlined in our white paper defines and describes the following steps and criteria:
- Titrant standardization
- Specificity, i.e. the ability to assess the analyte
- Linearity of the analytical procedure (defined as the linear regression of the sample size versus the consumed titrant volume)
- Accuracy (defined as the closeness of the result to the true value)
- Precision (defined as standard deviation and evaluated in two levels: repeatability and intermediate precision)
The procedure is exemplified using a potassium bicarbonate sample.