Mrs/Miss Sood,

The so-called ''acceptance criteria'' have been determined according to so-called ISOs (https://www.iso.org/home.html). So that depending on your method, methodology, technique and analyte along with the matrix type you should check which are the ISO references and should follow the protocols.

If you achieve better method performances, then you can publish your results are new method-validation.

The acceptance criteria will depends of the official guides to be followed (ANVISA, ICH, AOAC ...). In Brazil, for example, there is the ANVISA resolution number 166 of 2017, which not only establishes acceptance range values, but suggests statistical analysis that demonstrate the reliability of the measures.

Naturally, each technique has its particularities in relation to the analytical sensibility of the detectors, sample pretreatment forms and equipment parameters, which in their entirety influence the work ranges and consequently the acceptance range.

Dear Bojidarka B. Ivanova & Valmir gomes de Souza

Thank you for your answer.

I am working on validation of 10 ions i.e. Fluoride, Chloride, Nitrite, Nitrate, Sulfate, Bromate, and Sodium, potassium, Calcium and Magnesium in water by ion chromatography.

I have all the experimental data with me, but i don't know the Acceptance criteria for different Validation parameters.

If you could suggest any reference, I shall be thankful.

Dear Ankita Sood, before we validate a method, we elaborated a protocol to be followed during the validation of the method. In this protocol we define which parameters will be monitored (usually based on official guides), as well as previously we consider the working ranges and limits of acceptance. As you already have the data, then just know which parameters you monitored and the purpose of the validated method (if it is quantification, identification, purity tests), based on this information you return to the guide that was used as the basis for choosing the parameters validation (specificity, selectivity, limits of quantification and detection, precision, accuracy, robustness, matrix effect, stability and others).

As I said in the previous message, we have several guides, such as ANVISA (Brazil), the AOCS (American Oil Chemists' Society). ICH Q2(r1) for validation parameters. I hope I have contributed to your work.

Dear Valmir gomes de Souza ,

Thank you so much for your valuable suggestion.

Dear Ankita

As attached file may help you for the criteria for method validation.

Hope that will help you.

Thippaya