한경문 (식품의약품안전평가원)

김유경 (식품의약품안전평가원)

김현경 (식품의약품안전평가원)

한경문 (식품의약품안전평가원)

김유경 (식품의약품안전평가원)

김형수 (식품의약품안전평가원)

김현경 (식품의약품안전평가원)

Hair loss is a disorder that requires medical treatment, but there is a tendency to manage it with cosmetics or foods rather than medical care. These products do not have the same therapeutic effects as medicines. Nevertheless, it is sold with exaggerated advertisements such as 'hair loss prevention, hair loss improvement, and hair loss treatment'. Some products are illegally added with pharmaceutical ingredients such as Minoxidil. However, there is a lack of analytical methods that detect illegal inclusion of these hair growth ingredients, which emphasizes the need to establish these analytical methods.

In this study, we developed an HPLC method that simultaneously analyzes 17 hair growth ingredients by comparing detection wavelength, mobile phase, and column. As a result of comparing various factors, the chromatographic separation was optimized using the Onyx monolithic HD-C18 column (130 Å, 4.6 × 100 mm) within 35 minutes. The method was validated for specificity, limit of detection (LOD), limit of quantification (LOQ), recovery, linearity, accuracy, and precision according to the ICH guidelines. As a result, the LODs and LOQs were 0.09-0.97 μg/mL and 0.26-2.94 μg/mL, respectively. The recoveries were 97.4-113.1% and RSDs were less than 3.9%. The linearity was demonstrated with R2 values higher than 0.999 for 17 analytes. The accuracies were 91.7-100.8% (intra-day) and 93.0-101.4% (inter-day), and the precisions were 0.2-4.5% (intra-day) and 0.1-2.3% (inter-day). We believe that the developed method will help to prevent the distribution of illegal hair growth products proactively.

Acknowledgement: This research was supported by a grant (24211MFDS245) from Ministry of Food and Drug Safety in 2025.