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AMV Parameters for Related Substance and Assay

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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Hello
I have a product Hydrochlorothiazide as per USP.
I would like to carry out Analytical Method Validation for this product.
There are two Tests in the USP.
1. Related substance and 2. Assay
Both of the tests are on HPLC and the chromatographic conditions are same for both.
Assay and related substance both are calculated from the same chromatogram.
So, Which parameters should I have to include while conducting AMV for Releted substance and also for Assay?

Thank You
Follow ICH Q2A for drug substance; Q2B for drug product. Linearity should be from LOQ to 120% of assay concentration.
Follow ICH Q2A for drug substance; Q2B for drug product. Linearity should be from LOQ to 120% of assay concentration.

Thank You very much
3 posts Page 1 of 1

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