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2. Usage-Case Examples                                                                                                    2-2.  Pharmaceutical Preparation Development Studies:
            2-1.  API Process Studies: Outputting Scouting Results for Chiral Compounds                                                     Outputting Trend Plots for Dissolution Testing
                                                                                                                                      Dissolution testing is widely used in the field of pharmaceutical de-  "DT Solution" offers the ability to not only create an analysis se-
            In the API research area, chiral columns are being studied for quick   quantitative analysis of the large volumes of data acquired during   velopment for development and quality control activities, and also in   quence  starting  with  the  System  Suitability  Test  (SST),  but  it  also
            and efficient resolution of optical isomers. Finding the appropriate   method scouting.                                   the  field  of  generic  drugs  for  bioequivalence  testing.  With  an  in-  makes it possible to include information needed to calculate the dis-
            column and mobile phase conditions for a given analysis from the   Fig. 2 shows data obtained from methylclothiazide screening and   creasing number of working hours being accounted for by the grow-  solution  rate,  such  as  sample  interval  and  measured  component
            wide variety of chiral columns available is a time-consuming and la-  Fig. 3 compares different resolution conditions. Data are displayed as   ing numbers of test samples, there is demand for a means of reduc-  weight, within the data. The Multi Data Report function then uses
            bor-intensive process, so there is a demand for more efficient means   graphs ranked in the order of degree of resolution, so the user can   ing the time spent in determining results from dissolution testing.  this information to calculate the dissolution rate.
            of developing separation conditions for chiral compounds.  quickly determine the most appropriate column and resolution con-
            Shimadzu offers a "Method Scouting System," which by combining   ditions for a given chiral compound.                     In pharmaceutical preparation development, the dissolution of phar-  Fig. 5 is a report with a plot showing the trend in dissolution rate.
                                                                                                                                      maceutical preparations is checked by creating a report in the form of
                                                                                                                                                                                           This method offers the ability to automate operations, from analysis
            solvent switching valves and column switching valves, is capable of   In addition to the degree of resolution, other parameters obtained   a time-series plot of dissolution rate at short sampling intervals. Since   to report. In addition, Multi Data Reports also make it possible to au-
            automatically and continuously acquiring comprehensive data from   during analysis such as the symmetry factor, number of peaks de-  dissolution rates must be calculated using formulas in the Pharmaco-  tomatically calculate the dissolution rate from the measured weight
            up to 192 column and mobile phase combinations. However, deter-  tected, and number of theoretical plates can be used freely to create   poeia, reports are commonly created using Excel and so validation and   and display this information graphically as a trend plot.
            mining  optimum  resolution  conditions  from  the  large  volumes  of   evaluations according to the application.        the control of templates used in this work often presents problems.
            data obtained during method scouting is time-consuming work that                                                                                                               Report templates can be stored securely in the LabSolutions data-
            has its own set of issues, such as different operators generating dif-  This method removes operator influence from column scouting, and   The Multi Data Report function described in this article can be used   base, and report template change histories can be saved as an audit
            ferent results from the same dataset.                through the use of qualitative data also improves the reliability of   alongside the dedicated dissolution testing software "DT Solution,"   trail, freeing the operator from administrative tasks.
                                                                 scouting results.                                                    which reduces the work involved in creating complex reports and in
            The Multi Data Report function described in this article facilitates
                                                                                                                                      file management.

                                                Scouting Report Summary
                 Rank           Data File      Evaluation Value Peak Count Separated Peak Count Resolution Resolution Factor Tailing Factor1 Tailing Factor2  k'1  k'2  Area%1  Area%2
                     Methylclothiazide_ID_n-Hex_EtOH_3_analysis_B20%_14min_035.lcd  7.569  2  2  3.785  1.523  1.310  1.463  5.665  8.626  49.777  50.223
                     Methylclothiazide_IF_MC_EtOH_6_analysis_B2%_4min_078.lcd  6.173  2  2  3.086  1.858  1.127  1.094  1.390  2.583  52.748  47.252
                     Methylclothiazide_IB_MC_EtOH_6_analysis_B2%_4min_070.lcd  4.912  2  2  2.456  2.248  0.715  1.094  0.443  0.995  45.633  54.367
                    4 Methylclothiazide_IC_n-Hex_EtOH_3_analysis_B20%_14min_033.lcd  3.155  2  2  1.577  1.238  1.264  1.300  2.821  3.493  47.960  52.040
                    5 Methylclothiazide_IF_n-Hex_EtOH_4_analysis_B100%_18min_052.lcd  3.030  2  1  1.515  2.759  1.465  -  0.102  0.282  48.153  51.847
                    6 Methylclothiazide_IF_MTBE_EtOH_8_analysis_B2%_4min_104.lcd  2.602  2  0  1.301  1.327  -  -  1.361  1.806  48.306  51.694
                    7 Methylclothiazide_IF_n-Hex_IPA_2_analysis_B40%_14min_026.lcd  2.433  2  1  1.217  1.807  1.854  -  1.436  2.595  48.504  51.496
                    8 Methylclothiazide_IA_n-Hex_EtOH_3_analysis_B20%_14min_029.lcd  2.326  2  0  1.163  1.156  -  -  4.943  5.714  48.006  51.994
                    9 Methylclothiazide_IC_n-Hex_IPA_2_analysis_B40%_14min_020.lcd  2.295  2  0  1.147  1.296  -  -  1.962  2.543  48.356  51.644
                    10 Methylclothiazide_IA_MTBE_EtOH_8_analysis_B2%_4min_094.lcd  2.202  2  0  1.101  1.209  -  -  2.128  2.573  46.618  53.382
                                                   Fig. 2  Screening Results Summary

                                           ®
                 mAU  [Rank 1st] Column: CHIRALPAK  ID
                  150


                                                                                                                                                                                  Fig. 4  DT Solution
                  100

                  50

                                                                           Analytical conditions
                   0
                                                                           • Mobile phase   : Hexane/Ethanol=8/2 (v/v)
                    0.0      2.5      5.0      7.5     10.0     12.5  min  • Flowrate     : 3 mL/min
                     [Rank 4th] Column: CHIRALPAK  IC                      • Analysis time   : 14 min
                                           ®
                 mAU
                  250                                                      • Column temperature : 40 °C
                                                                           • Injection volume   : 10 µL
                  200
                  150
                  100

                  50
                   0
                    0.0      2.5      5.0      7.5     10.0     12.5  min
                                                Fig. 3  Comparison of Resolution Conditions                                                                                    Fig. 5  Trend Graph Report

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