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Peer-Reviewed Publication
J Pharm Sci2025;114(5):103714.May 1, 2025Journal Article

Efficient evaluation of the precision of quantitative chromatographic analysis of soft capsules using a chemometric tool.

Ai Sano1, Akira Kotani2, Hideki Hakamata2, Masato Takahashi3
1TOYO CAPSULE Co., Ltd., 560 Nakazato-higashi-cho, Fujinomiya-shi, Shizuoka, 418-0046, Japan. Electronic address: a8_sano@toyo-cap.co.jp.
2School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan.
3TOYO CAPSULE Co., Ltd., 560 Nakazato-higashi-cho, Fujinomiya-shi, Shizuoka, 418-0046, Japan; Graduate School of Pharmaceutical Sciences, Kumamoto University, 5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan.

Abstract

Soft capsules may enhance oral absorption and bioavailability of active substances by appropriately combining them with excipients such as lipids and surfactants. However, these excipients affect the determination of active substances and warrant several considerations for establishing optimal analytical methods. The function of mutual information (FUMI) theory is a chemometric tool that estimates…

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