Validating an hplc method


13-Feb-2021 11:41

This inevitably requires methods which generate high-quality results.Method development is a core capability at Averica.The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.Possible steps for a complete method validation are listed in Table 1.The validation procedure in this particular article is based on requirements for EU multistate registration.Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.The scope of the method and its validation criteria should be defined early in the process.

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It meets criteria such as ease of use; ability to be automated and to be controlled by computer systems; costs per analysis; sample throughput; turnaround time; and environmental, health and safety requirements.

Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.



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