LC method development and validation

Investigation of peak homogeneity is an important topic in the validation of the analytical methodology. Method validation requirements are described in the ICH guidelines [1]. Method development involves the separation of drug 

Caution needs to be exercised in confirmation of method specificity, as peak purity cannot be inferred from the absence of any mass spectrometric signals, as an absence could be because of ion suppression, or the response may too low to be detected, or the unknown may have different ionisation properties. Peak purity should be tested by using an orthogonal technique. 

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