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.
MA Ling-yun
,
MENG Yu-xin
,
ZHAI Chen-fei
,
FENG Yu-fei
,
LIU Qian
,
NIU Jian-zhao
. 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
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