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目的采用HPLC法同时测定萘敏维滴眼液中常用的9种抑菌剂,以筛查该滴眼液中所含抑菌剂的种类与含量是否与处方标注内容一致。方法以保留时间和二极管阵列检测器(DAD)光谱图作为定性依据,采用HPLC-DAD法同时对19家生产企业的192批萘敏维滴眼液中的9种抑菌剂(羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯、苯扎溴铵、苯扎氯铵、度米芬、三氯叔丁醇、硫柳汞)进行定性定量分析。结果定性结果表明:181批样品所含抑菌剂的种类与处方标注的一致,11批样品的不一致;定量结果表明:抑菌剂含量在处方量的50%~120%。结论所用方法适用于萘敏维滴眼液中抑菌剂的质量控制。建议在萘敏维滴眼液的质量标准中设置抑菌剂的含量检查项。
OBJECTIVE To determine the nine kinds of bacteriostats commonly used in naphthalenemicarbazole eye drops by HPLC to screen whether the type and content of bacteriostats contained in the eye drops are the same as those of the prescriptions. Methods The HPLC-DAD method was used to determine the nine antibacterial agents (methylparaben , Phenethyl, propylparaben, butylparaben, benzalkonium bromide, benzalkonium chloride, domiphen, chlorobutanol, thimerosal) were qualitatively and quantitatively analyzed. Results The qualitative results showed that the types of bacteriostats contained in 181 batches of samples were the same as the prescriptions, and the inconsistency was found between the 11 batches of samples. The quantitative results showed that the content of bacteriostat was 50% ~ 120% of the prescription. Conclusion The method is suitable for the quality control of antibacterial agents in naphthalenemicarbazole eye drops. It is recommended to set the content of bacteriostat check items in the quality standards of naphthalene eye drops.