HPLC with charged aerosol detection for pharmaceutical cleaning validation

Cleaning validation is a major analytical application in the pharmaceutical industry. Here, high performance liquid chromatography (HPLC) with charged aerosol detection is compared and contrasted to HPLC with UV detection showing comparable performance and several advantages for charged aerosol detection, especially for analytes that do not contain a chromophore. Quantitation of drug substance is demonstrated along with the potential of charged aerosol detection for nonchromophoric excipients, providing an accurate assessment of residual contaminants remaining on the cleaned equipment. The utility of charged aerosol detection for use in pharmaceutical cleaning validation by HPLC is discussed and a practical application of this technique is described.