The Frustrated Reviewer - Recurrent Failures in Manuscripts Describing Validation of Quantitative TLC/HPTLC Procedures for Analysis of Pharmaceuticals

摘要

Analytical procedures to be used in pharmaceutical quality control have to be validated strictly in accordance with highly formalized standards and guidance. Manuscripts submitted for publication presenting new procedures must therefore describe the corresponding validation characteristics and the validation approach and procedure accordingly. Interestingly, many of these manuscripts and -what is worse - already published (and therefore accepted) articles in various periodicals are characterized by several typical methodological failures and misconceptions - even though authors have regularly been informed of such mistakes in the hope they can be avoided. The corresponding ICH guideline seems to be well-known, and is frequently cited in these manuscripts, but to some extent is not fully understood and is even partially neglected. In this paper the authors present a collection of typical failures, misconceptions, and misleading data captured as reviewers and readers of published articles over the last two years, thus giving a survey of the most frequent problems of TLC/HPTLC validation. Moreover, the authors provide a list of references describing optimum approaches to validation of specific TLC/HPTLC procedures. We suggest these are followed in addition to the general concepts of the ICH guideline.