Establishment and evaluation of determination methods of nine antimicrobial agents in Compound Dexamethasone Acetate

OBJECTIVE to establish an HPLC method for the simultaneous determination of 9 common antimicrobial agents in compound dexamethasone acetate cream and gel. The samples from 44 domestic manufacturers that were sampled and inspected by the national drug in 2018 were tested and evaluated. METHODS Waters xbridge shield RP18 column(4.6 mm×250 mm, 5 μm) was used, 1% triethylamine solution(pH adjusted to 3.0 by phosphoric acid) (mobile phase A) and acetonitrile(mobile phase B) were used for gradient elution, and the detection wavelength was 215 nm. The method was used to detect the samples in domestic, and to evaluate the effectiveness and safety of the antibacterial agent in the compound preparation. RESULTS Under this chromatographic condition, 9 kinds of bacteriostatic agents were separated well, the linear relationships were good in the range of 1-70 μg·ml^-1, the average recoveries were 91.2%-100.4%, and the RSDs were 0.1%-6.7%. Five bacteriostatic agents, namely bropol, methylparaben, ethylparaben, propyl 4-hydroxybenzoate and benzalkonium bromide, were detected in the samples, and the concentration of the antimicrobial agents ranged from 0.48-2.89 mg·g^-1. CONCLUSION There are some irregularities in the use of antimicrobial agents in the samples. This study can provide technical support for the standardized use of antimicrobial agents in this variety.