Validating Analytical Methods with Charged （验证分析方法与起诉）.pdf

Validating Analytical Methods with Charged Aerosol Detection Christopher Crafts, Bruce Bailey, Marc Plante, and Ian Acworth Thermo Fisher Scientific, Chelmsford, MA, USA Abstract As the need for universal detectors increases in This work evaluates data reported in several peer- regulated environments, the design of experiments reviewed publications as well as detailing the validation specific to nebulizer-based detector platforms becomes of an HPLC-UV-CAD method developed for the more important. As shown in this work, a more complex simultaneous analysis of an active pharmaceutical analytical system was able to remove matrix effects, ingredient (API) and its counterion recovered from a final significantly decrease run time, and maintain the needed dose tablet. reproducibility. This savings in time enabled the replicate injections needed to create a robust and accurate Naproxen tablets were treated with a dissolution matrix method. The use of mixed detection platforms should of Tween® 80/formic acid/DI water for 4 h with periodic be encouraged if a multicomponent analysis is required, sampling. The HPLC method used a dual-gradient pumping where universal detection is needed for some but not all system with two C18 columns in tandem for sample clean of the analytes. up. A mixed-mode column was then used for the retention and analysis of both the API (naproxen) and the counterion Introduction (sodium). The final method took 15 min per injection There are currently over 60 peer-reviewed publications and allowed for complete flush and reconditioning of the discussing the application of charged aerosol detection analytical