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Application News No. G318 Gas Chromatography System Suitability Test of Low-Substituted Hydroxypropyl Cellulose for USP42-NF37 On May 1st, 2019, the United States Pharmacopeia (USP) monograph for the low-substituted hydroxypropyl cellulose was shifted its GC method with a packed column to one with a capillary column in USP42-NF37. This article shows that Shimadzu Nexis™ GC-2030 AF satisfies system suitability requirements set in USP42-NF37. Y. Nagao Test Method As a standard solution, isopropyl iodide was diluted in a mixed solution of o-xylene and hydroiodic acid with n-octane also added as an internal standard in accordance with the USP monograph. Table 1 below shows the instrument composition and analysis conditions. The column flow rate was set in such a way that the internal standard elutes in approximately 10 mins as suggested in the USP. Verification of System Suitability Fig. 1 shows the chromatogram obtained by injecting 1 μL of the standard solution. <Resolution> One of the system suitability requirements by the USP is resolution between isopropyl iodide and n-octane (IS) be greater than 5. In this experiment, resolution was measured 28.3. <Relative standard deviation> For repeatability, with the injection volume being 1-2 μL, relative standard deviation (n=6) of peak areas of isopropyl iodide corrected by those of the internal standard be less than 2.0%. The chromatograms from the 6 SST injections were shown in Fig. 2. In this experiment, RSD% of the peak areas of isopropyl iodide corrected by those of n-octane (IS) was 0.083%. The actual peak areas of isopropyl iodide and n-octane obtained in this experiment are listed in Table 2. Fig. 1 Chromatogram of Standard Solution Table 1 Instrument Composition and Analysis Conditions Model : Nexis GC-2030AF (230 V) /AOC™-20i Column : InertCap-1 (30 m, 0.53 mm I.D., df=3.0 μm) Column Temp. : 50 °C (3 min) - 10 °C/min - 100 °C - 35 °C/min - 250 °C (8 min) Detector : FID Carrier Gas : He, 2.8 mL/min Inj. Temp. : 250 °C Det. Temp. : 280 °C Split Ratio : 40 Inj. Volume : 1.0 μL 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 min Isopropyl iodide Internal standard (n-octane)
Application News No. G318 First Edition: Feb. 2020 For Research Use Only. Not for use in diagnostic procedures. This publication may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country. The content of this publication shall not be reproduced, altered or sold for any commercial purpose without the written approval of Shimadzu. Shimadzu disclaims any proprietary interest in trademarks and trade names used in this publication other than its own. See http://www.shimadzu.com/about/trademarks/index.html for details. The information contained herein is provided to you "as is" without warranty of any kind including without limitation warranties as to its accuracy or completeness. Shimadzu does not assume any responsibility or liability for any damage, whether direct or indirect, relating to the use of this publication. This publication is based upon the information available to Shimadzu on or before the date of publication, and subject to change without notice. © Shimadzu Corporation, 2020 www.shimadzu.com/an/ Fig. 2 Comparison of Chromatograms of Standard Solution (n = 6) Table 2 Peak Areas of Isopropyl Iodide and Internal Standard (n-Octane) Isopropyl iodide Internal standard (n-octane) Peak area ratio Peak area μV x s Peak area μV x s n=1 1657971 7972428 0.207 n=2 1678243 8056098 0.208 n=3 1673697 8034163 0.208 n=4 1656798 7948074 0.208 n=5 1643823 7893254 0.208 n=6 1649018 7912827 0.208 Repeatability RSD% 0.816 0.817 0.083 Conclusion System suitability test of low-substituted hydroxypropyl cellulose for the United States Pharmacopeia (USP) 42-NF37 was performed with Shimadzu Nexis GC-2030. As a standard solution, isopropyl iodide was diluted in a mixed solution of o-xylene and hydroiodic acid with n-octane also added as an internal standard in accordance with the USP method. In this experiment, satisfactory results were obtained for both resolution and repeatability, confirming that Shimadzu Nexis GC-2030 satisfies system suitability required by USP42-NF37. Nexis is a trademark of Shimadzu Corporation in Japan and/or other countries. AOC is a trademark of Shimadzu Corporation. n=6 n=5 n=4 n=3 n=2 n=1 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5 13.0 13.5 14.0 min Internal standard (n-octane) Isopropyl iodide
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