Objective: To establish an HPLC method for determining trace genotoxic impurities in furosemide and its preparations. Methods: The chromatographic column was filled with octadecylsilane bonded silica gel,with phosphoric acid solution and acetonitrile as mobile phase,and the detection wavelength was 270 nm. Results: The known impurities in the pharmacopoeia did not interfere with the detection. The detection limit of impurities was 12 ng·mL-1. The linearity between 0.04-4.088 μg·mL-1 was good,r2=1.000. The average recoveries of furosemide and its preparations were 99.8%(RSD=2.8%),98.9%(RSD=0.9%)and 100.9%(RSD=2.4%). There were 0.003%-0.004% furfural detected in furosemide and its commercial preparations. Conclusion: This method has high specificity,sensitivity and good accuracy,and can be used to detect furfural,a trace gene toxin impurity in furosemide and its preparations. This method ensures the efficacy and safety of furosemide preparations.
ZHAO Ya-nan, HE Nian-ping, HAN Shu-xian, ZHU Ya-fang
. Determination of trace genotoxic impurities in furosemide and its preparations[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(9)
: 1534
-1537
.
DOI: 10.16155/j.0254-1793.2021.09.06
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