김미진 (식품의약품안전평가원)

김현경 (식품의약품안전평가원)

김미진 (식품의약품안전평가원)

최환성 (식품의약품안전평가원)

안범균 (식품의약품안전평가원)

김형수 (식품의약품안전평가원)

김현경 (식품의약품안전평가원)

Selective estrogen receptor modulators (SERMs) are compounds that exhibit tissue-specific estrogen receptor agonist or antagonist activity. In Korea, this substances are used as medicines for the treatment of breast cancer, osteoporosis, ovulation inducer. However, there have been numerous reports, both domestically and internationally, about the illegal use of these compounds to alleviate side effects(such as gynecomastia and decreased libido) from anabolic steroids or selective androgen receptor modulators(SARMs) used for muscle enhancement. In order to safeguard public health against such threats, this study aimed to develop a validated analytical method capable of simultaneous identification and quantification of various SERMs.

In this study, a total of 7 compounds were selected, including clomiphene and tamoxifen, which had been previously found from illegal products. An analytical method was developed for both liquid and solid matrices using LC-MS/MS and validated as follows: LODs (0.10-8.40 ng/mL) and LOQs (0.21-2.90 ng/mL), linearities (R2>0.99), matrix effects (95.72-106.66%), acuuracy (88.50~110.59%) and precision (RSD>9.08%), and recoveries (91.99-116.18%). This simultaneous analytical method can serve as a powerful tool for identifying illegal products containing SERMs and contribute to the protection of public health.

* This research was supported by a grant (24211MFDS244) from Ministry of Food and Drug Safety in 2025.