Characterization of Genotoxic Impurities with LC-QTOF and RP-HPLC Methods, Including Different Swab Methods in Cleaning Validation
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Abstract
While cleaning agents used in cleaning validation studies eliminate product residues, they can create another contamination with their own residues. This study aims to develop a new, more economical, and easy-to-apply strategy that can achieve sharp peaks by using the UV-RP-HPLC method in cleaning validation studies on different surfaces and the swab method in cleaning validation studies. The content of the cleaning agent used in cleaning validation studies was characterized by mass spectroscopy (LC-QTOF-MS). According to the International Council for Harmonization, a new, easy-to-apply method for propylbenzene sulfonate detected in the cleaning agent composition was developed and verified by the UV-RP-HPLC method. PMMA, POM, Teflon, and glass plate surfaces were used for the swab method. The residue limit was calculated at 71.4 µg/mL. The absence of any cleaning validation studies using specific plate surfaces such as PMMA, POM, Teflon, and glass for propyl benzene sulfonate as a genotoxic impurity, characterized by LC-QTOF-MS and swab method in the current literature, supports the innovative contribution of our study. Validated according to the ICH Q2 (R1) guideline, this method showed linearity, precision, accuracy, solution stability, and system suitability results within acceptance criteria.
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