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Determination of five acid radicals in chemical reference substances by ion chromatography
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Ling-yun MA, Yu-xin MENG, Chen-fei ZHAI, Yu-fei FENG, Qian LIU, Jian-zhao NIU*
Chinese Journal of Pharmaceutical Analysis | 2024, 44(10) : 1741 - 1748
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(10): 1741-1748
Ingredient Analysis
Determination of five acid radicals in chemical reference substances by ion chromatography
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Ling-yun MA, Yu-xin MENG, Chen-fei ZHAI, Yu-fei FENG, Qian LIU, Jian-zhao NIU*
Affiliations
  • National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2024-10-31 doi: 10.16155/j.0254-1793.2024-0275
Outline
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Objective:

To establish an ion chromatography method suitable for simultaneous determination of acid radical content in chemical reference substances containing methanesulfonic acid,hydrochloric acid,phosphoric acid,sulfuric acid and butadisulfonic acid.

Methods:

The chromatographic column of Metrosep A Supp 5 250/4.0 (250 mm×4.0 mm,5 μm) was used with 6.4 mmol·L-1 Na2CO3 and 2.0 mmol·L-1 NaHCO3 as the eluent with a flow rate of 0.7 mL·min-1. Column temperature was 30 ℃.

Results:

Methanesulfonate (19.1-71.7 μg·mL-1),chloride ion (2.6-25.8 μg·mL-1),phosphate (7.0-26.3 μg·mL-1),sulfate (6.8-51.0 μg·mL-1),and succinate (21.3-105.5 μg·mL-1) had good linear relationships within their respective ranges (r≥0.999 5). Precision (RSD≤2%),stability (RSD≤2%) and repeatability (RSD≤2%) were good. The average recovery rates (n=9) were 98%-102%. Calculated as salt formation,the content of mesylate in amlodipine mesylate was 23.69%,the content of hydrochloric acid in guanfacine hydrochloride was 12.66%,the content of phosphoric acid in reagliptin phosphate was 17.38%,the content of sulphate in salbutamol sulfate was 16.49%,and the content of butyldisulfonic acid in adenosine butyldisulfonic acid was 45.61%. The deviation between theoretical and measured values was less than 0.50%. The measured values were close to the theoretical values.

Conclusion:

The method is suitable for the screen and determination of acid radicals in chemical reference products containing methanesulfonic acid,hydrochloric acid,phosphoric acid,sulfuric acid and butadisulfonic acid.

methanesulfonic acid  /  hydrochloric acid  /  phosphoric acid  /  sulfuric acid  /  butadisulfonic acid  /  content determination  /  chemical reference substance  /  ion chromatography
Ling-yun MA, Yu-xin MENG, Chen-fei ZHAI, Yu-fei FENG, Qian LIU, Jian-zhao NIU. Determination of five acid radicals in chemical reference substances by ion chromatography[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (10) : 1741 -1748 . DOI: 10.16155/j.0254-1793.2024-0275
Year 2024 volume 44 Issue 10
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doi: 10.16155/j.0254-1793.2024-0275
  • Receive Date:2024-04-24
  • Online Date:2026-03-15
  • Published:2024-10-31
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  • Received:2024-04-24
Affiliations
    National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数

Family
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Number of
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Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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