复方醋酸地塞米松制剂中9种抑菌剂含量测定方法的建立及评价

目的 建立HPLC同时测定复方醋酸地塞米松乳膏、凝胶中可能含有的9种常见抑菌剂的方法.对2018年国家药品抽验到的国内44个生产厂家的样品进行检测及评价.方法 采用Waters Xbridge Shield RP18色谱柱(4.6 mm×250 mm,5μm);以1％三乙胺溶液(加磷酸调节pH至3.0)为流动相A,乙腈...

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.