Content Determination of Ethylenediaminetetraacetic Acid Disodium in Compound Ammonium Glycyrrhetate Series Injections by HPLC
Objective To establish a high-performance liquid chromatography(HPLC)method for the rapid determination of ethylenediaminetetraacetic acid disodium(EDTA-2Na)in Compound Ammonium Glycyrrhetate Series Injections.Methods The chromatographic column was Hypersil GOLD C18 column(250 mm×4.6 mm,5 µm),the mobile phase was 50 mmol/L sodium dihydrogen phosphate solution(containing 5 mmol/L tetrabutylammonium bromide,pH was adjusted to 4.5 with phosphoric acid solution)-acetonitrile(90∶10,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 257 nm,the column temperature was 40℃,and the injection volume was 10 µL.Results The mass concentration of EDTA-2Na showed a good linear relationship with EDTA-Fe3+ in the range of 2-200 µg/mL(R2 = 0.999 8,n = 7).The limit of detection(LOD)was 0.02 µg/mL,and the limit of quantitation(LOQ)was 0.06 µg/mL.The RSDs of precision,repeatability,and stability tests were lower than 2.0%.The average recoveries of Compound Ammonium Glycyrrhizin Injection,Compound Ammonium Glycyrrhetate Injection,Compound Ammonium Glycyrrhetate S and Sodium Chloride Injection,Compound Ammonium Glycyrrhetate Cysteine Sodium Chloride Injection,and Compound Ammonium Glycyrrhetate S for Injection were 100.57%,100.90%,100.86%,100.95%,and 101.03%with RSDs of 0.21%,0.82%,0.60%,0.64%,and 0.67%(n = 9),respectively.No EDTA-2Na was detected in the samples from two manufacturers,and the content of EDTA-2Na in the samples from seven manufacturers exceeded the concentration(m/V)range of 0.005%-0.1%.The content of EDTA-2Na in the samples from other manufacturers was within the limited concentration range.Conclusion This method is simple,reproducible,and accurate,which can be used for the determination of EDTA-2Na in Compound Glycyrrhetate Series Injections.The additional amount of EDTA-2Na in samples from different manufacturers varies greatly,and its rationality needs to be further improved.
Compound Glycyrrhetate Series InjectionsEDTA-2NaHPLCrapid determinationrationality evaluation
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