ICH Q14 ‐inspired novel approach to establish an SFC‐based purity method for carbamazepine

Analytical quality by design (AQbD) principles as described in the proposed ICH Q14 guideline were used to develop a supercritical fluid chromatography (SFC)-based purity method for carbamazepine. The resulting method is an alternative to the official HPLC method published in the Ph.Eur. with improved peak resolution, improved peak symmetry, and much faster analysis times (3 min vs. 80 min for the official method). AbstractThe proposed ICH Q14 guideline “Analytical procedure development” describes science and risk-based approaches for development and maintenance of analytical procedures suitable for the assessment of the quality of drug substances and drug products. As a case study, the systematic development and validation of a supercritical f luid chromatography (SFC)-based purity method for carbamazepine is presented. Systematic analytical quality by design (AQbD) principles were applied using the software package Fusion QbD to the method development approach. The relationship between chromatographic parameters and the responses of inte rest were examined to improve the reliability of the method by understanding, reducing, and controlling sources of variability. Method performance qualification in terms of method robustness was finally carried out with the parameters that were classified as critical after method development and a v alidation study met previously set acceptance criteria. The developed SFC purity method for carbamazepine demonstrated readiness as a viabl...
Source: Drug Testing and Analysis - Category: Drugs & Pharmacology Authors: Tags: RESEARCH ARTICLE Source Type: research