Objective To establish an HPLC method for the simultaneous determination of 12 common bacteriostatic agents(benzoic acid,benzyl alcohol,sorbic acid,methylparaben,thimerosal,ethylparaben,chlorhexidine acetate,propyl hydroxybenzoate,butyl p-hydroxybenzoate,benzalkonium bromide,domiphen bromide,benzalkonium chloride)in brimonidine tartrate eye drops.The 48 batches of samples collected from 4 domestic manufacturers were tested and evaluated.Methods Shiseido CAPCELL PAK C18 MGII column(4.6 mm×250 mm,5 μm)was used,0.02 mol/L ammonium acetate(pH adjusted to 4.5 by glacial acetic acid)(mobile phase A)and methyl alcohol(mobile phase B)were used for gradient elution,and the detection wavelength was 262 nm.Results The separation degree of 12 bacteriostatic agents reached the requirements,and the blank excipients did not interfere with the determination of bacteriostatic agents,the linear relationship of bacteriostatic agents in their linear range was good,the average recoveries were in the range of 92.8%to 105.7%and the RSDs were 0.3%～1.9%(n=9).The qualitative analysis showed that the types of bacterial inhibitors in 48 batches were all in agreement with the formulation.The quantitative determination showed that the contents of bacterial inhibitors were between 24%～102%of the formulation.Conclusion The method is sensitive,rapid and specific,and can be used for the accurate quantitative determination of multiple bacteriostatic agents in brimonidine tartrate eye drops.This study can provide technical support for the standardized use of bacteriostatic agents in this variety.
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