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HITACHITechnical Report1nspire the NextAS/LC-054 High-Performance Liquid ChromatographAnalysis of D-Mannitol in Japanese Pharmacopoeia Sixteenth Edition Supplement Ilhttp://www.hitachi-hitec-science.comC2015 Hitachi High-Tech Science Corporation The test items for D-mannitol in the Japanese Pharmacopoeia Sixteenth Edition Supplement ll, whichwas put into force in February 2014, have been revised, and the analysis by HPLC has been added.For D-mannitol, the analysis for Purity (4) Related Substances and Quantitative Method is performedat 85°C with a 300 mm column, and thus a large column capacity as well as the temperature control toensure stable analysis even at a high temperature will be required.Chromaster 6310 Column Ovencan store a maximum of three 300 mm columns. It provides a wide temperature setting range of 4-90°C and excellent temperature stability and is capable for the low volume preheating to reduce thepeak diffusion. As a result, the system can be used for various applications. This time, the analysis ofD-mannitol was performed under the conditions for Quantitative Method described in the JapanesePharmacopoeia Sixteenth Edition Supplement Il and the analysis is introduced here. High Performance LiquidChromatograph Chromaster@ Quantitative Method of D-Mannitol- Confirmation of System Suitability Standard solution: 0.5 g of D-mannitol is dissolved in purified water, and the volume is made up to 10mL (5%). System suitability test solution (1): 0.25 g of D-mannitol and 0.25 g of D-sorbitol are dissolved in purified water, and the volume ismade up to 10 mL (2.5% each). System suitability test solution (2):0.5 g of maltitol and 0.5 g of isomalt are dissolved in purified water, and the volume is made up to100 mL (0.5% each). Purified water is added to 2 mL of this solution to make the volume to 10 mL (0.1% each). Table 2 shows the result of the system suitability test for the Quantitative Method of D-mannitol. Results satisfying the specificationswere obtained for all the items. Figure 1 Chromatogram of System Suitability Test Solution (1) Figure 2 Chromatogram of System Suitability Test Solution (2) Table 1 Analytical Conditions Figure 3 Chromatogram of Standard Solution Column(Transgenomic) CARBOsep COREGEL-87C7.8 mm l.D. X 300 mm Mobile phase H20 Flowrate 0.5 mL/min Column temperature 85°C Detector RI (Cell temperature: 40℃) Injection vol. 20 pL Table 2 Quantitative Method of D-Mannitol -System Suitability Test Result Item Specificationvalue Result System performance (relative retentiontime) (Figure 1, Figure 2) D-Mannitol-Isomalt (1)D-Mannitol-Maltitol D-Mannitol-Isomalt (2) D-Mannitol-D-Sorbitol Approx.0.6Approx.0.69Approx. 0.73Approx. 1.2 0.630.690.731.23 System performance (resolution)(Figure 1) D-Mannitol-D-Sorbitol NLT 2.0 5.74 System reproducibility (Figure 3) D-Mannitol Relative standard deviation (n=6) of peak area (%) NMT 1.0 0.21
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