Method Validation:

a.       Introduction: Definition of validation and its Importance

b.       Types of Methods to be validated

c.       General approach to method validation

d.      Validation parameters

                                                               i.      Accuracy         

1.      Comparison to a standard

2.      Analyte recovery

3.      Recommended data

                                                             ii.      Precision         

1.      Injector precision (reproducibility)

2.      Repeatability

3.      Recommended data

                                                            iii.      LoD and LoQ 

1.      Based on visual evaluation

2.      Based on S/N ratio

3.      Based on standard deviation of the response and slope

                                                           iv.      Linearity

                                                             v.      Range

                                                           vi.      Specificity

1.      Identification

2.      Assay and Impurity test

                                                          vii.      Ruggedness

                                                        viii.      Robustness

                                                           ix.      System Suitability Test

e.       Method validation protocol