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            At Eisai, Yamamoto et al. analyzed a liposome preparation with an   8. Conclusion
            SPE-SPE-HPLC system utilizing MAYI-ODS. In this research, it was   Using a system combining the Shim-pack MAYI biological sample
            possible to simultaneously quantify liposomal doxorubicin and   pretreatment column and Co-Sense for BA, plasma, serum and
            released doxorubicin in plasma, and this has even been applied to   other biological samples can be injected directly in large volumes
            a PK study utilizing mice [15].
                                                               for analysis. High-concentration proteins and electrolytes,
                                                               unnecessary components, are almost completely removed, and
                                                               stable data can be obtained even for unstable components, with
            7. Ideal in Combination with Shimadzu UFMS Series LC/MS
                                                               no loss of precious samples. In addition, the adoption of
            Speed and Sensitivity Beyond Comparison            Shimadzu's proprietary dilution trap method maintains peak shape
            The LCMS-8050 triple quadrupole mass spectrometer is the top   and enhances sensitivity by concentrating the intended
            model in the Shimadzu UFMS series. It combines the world's   components, thereby providing stable recovery rates and
            fastest speeds with the highest class of sensitivity. It provides 5   reproducibility. Furthermore, the system demonstrates its
            msec ultra-fast positive/negative ionization switching and 30,000   effectiveness in protecting analysis columns and the MS interface,
            u/sec ultra-fast scanning performance. As a result, quantitative   and reducing matrix effects. In terms of items required for method
            and qualitative measurements can be performed in parallel in a   validation, it contributes to the efficient attainment of highly
            single analysis by combining MRM and scan measurements.   reliable results. In the future, its application will likely extend to
            Quantitative accuracy is not lost even in such simultaneous   other types of analysis, including impurities related to ADCs and
            MRM/scan measurements.                             other biopharmaceuticals.
            Accordingly, highly reliable quantitative results and reliable
            qualitative information can always be obtained. In addition to high   References
            quantitative throughput, the system also demonstrates its
            strengths in the process of screening and optimizing analysis   [1] N.M. Cassiano, J.C. Barreiro, M.C. Moraes, R.V. Oliveira, Q.B.
            conditions.                                            Cass, Bioanalysis 1 (2009) 577.
            Furthermore, a contamination-resistant ionization interface has   [2] S.H. Yang, H. Fan, R.J. Classon, K.A. Schug, J. Sep. Sci. 36
            been adopted, and the design focuses on the robustness of the   (2013) 2922.
            system as a whole. Fig. 12 is a plot of area values, in which plasma   [3] N. Asakawa, H. Ohe, M. Tsuno, Y. Nezu, Y. Yoshida, and T.
            samples spiked with alprazolam were deproteinized, and then   Sato, J. Chromatogr., 1991, 541, 231
            analyzed consecutively 1,000 times. From the 1,000 data cycles,   [4] Y. Oda, N. Asakawa, T. Kajima, Y. Yoshida, and T. Sato, J.
            an excellent area value reproducibility of %RSD 4.59 % was   Chromatogr., 1991, 541,411
            obtained.                                            [5] E. Yamamoto, K. Murata, Y. Ishihama, N. Asakawa, Analytical
                                                                   Sciences (2001), 17(10), 1155-1159.
                                                                 [6] S. Kawano, H. Murakita, E. Yamamoto, N. Asakawa, J. Chro-
                                                                   matogr B (2003), 792(1), 49-54.
                                                                 [7] E. Yamamoto, T. Sakaguchi, T. Kajima, N. Mano, N. Asakawa,
                                                                   J. Chromatogr B (2004), 807(2), 327-334.
                                                                 [8] S. Kawano, M. Takahashi, T. Hine, E. Yamamoto, N. Asakawa,
                                                                   Rapid Communications in Mass Spectrometry (2005), 19(19),
                                                                   2827-2832.
                                                                 [9] T. Sakaguchi, E. Yamamoto, I. Kushida, T. Kajima, N. Asaka-
            Fig. 12 1,000 Consecutive Analyses of a Deproteinized Blood
                  Plasma Sample Spiked with Alprazolam (LCMS-8050)  wa, J. Pharm. Biomed. Anal. (2006), 40(2), 345-352.
                                                               [10] E. Yamamoto, S. Takakuwa, T. Kato, N. Asakawa, J. Chro-
                                                                   matogr. B (2007), 846(1-2), 132-138.
            In analyses involving plasma and other biological samples, ease of
            maintenance is an important point. With the LCMS-8050, the ESI   [11] Y. Sato, E. Yamamoto, S. Takakuwa, T. Kato, N. Asakawa, J.
            capillary is easily replaced, and the desolvation line can also be   Chromatogr. A (2008), 1190(1-2), 8-13.
            replaced without compromising vacuum, keeping downtime to a   [12] E. Yamamoto, H. Igarashi, Y. Sato, I. Kushida, T. Kato, T.
            minimum. In addition, Co-Sense for BA does not require special   Kajima, N. Asakawa, J. of Pharm. Biomed. Anal. (2006), 42(5),
            software, so with LabSolutions LCMS, everything from front-end   587-592.
            LC to LCMS can be controlled centrally from a single PC.  [13] E. Yamamoto, T. Kato, N. Mano, N. Asakawa, J. of Pharm.
                                                                   Biomed. Anal. (2009), 49(5), 1250-1255.
                                                                [14] www.fda.gov/downloads/AboutFDA/.../UCM341177.pdf
                                                                [15] E. Yamamoto, K. Hyodo, N. Ohnishi, T. Suzuki, H. Ishihara, H.
                                                                   Kikuchi, N. Asakawa, J. of Chromatogr. B (2011), 879(30),
                                                                   3620-3625.










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