Jieun Yong (식품의약품안전평가원 첨단분석과)

Hyun-Kyung Kim (식품의약품안전평가원 첨단분석과)

Inhyuk Yeo (식품의약품안전평가원 첨단분석과)

Jieun Yong (식품의약품안전평가원 첨단분석과)

In Suk Woo (식품의약품안전평가원 첨단분석과)

Kyoung-Moon Han (식품의약품안전평가원 첨단분석과)

Hyung Soo Kim (식품의약품안전평가원 첨단분석과)

Hyun-Kyung Kim (식품의약품안전평가원 첨단분석과)

Feminine cleansers require strict quality control due to their direct application to sensitive mucosal areas, making adulteration with illegally added pharmaceutical ingredients a critical public health concern. An accessible HPLC method was optimized for simultaneous determination of illegally added pharmaceutical ingredients indicated for vaginitis and urinary incontinence. Sample preparation was systematically optimized by comparing SPE and QuEChERS methods to maximize clean-up efficiency and minimize matrix effects from complex cosmetic formulations under UV detection. SPE demonstrated superior performance, with extraction recoveries of 95.47–106.18%, compared to 33.37–119.89% for QuEChERS. Hydrochloric acid (pH 2) served as washing solvent during SPE optimization to eliminate matrix interferences without analyte loss, while an acetonitrile/methanol mixture served as elution solvent to maximize desorption efficiency. Chromatographic separation was achieved through comprehensive evaluation of mobile and stationary phases. Finalized gradient conditions completely resolved all structurally diverse analytes. The LODs and LOQs ranged from 0.03 to 0.71 μg/mL and 0.09 to 2.16 μg/mL, respectively. Target compounds showed linearity with R2 values higher than 0.999.