Quality Control of Bacterial Inhibitor in Timolol Maleate Eye Drops

LIU He-ying;ZHOU Min;CHENG Qi-zhen;KE Rong;Jiangxi Institute for Drug Control;Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality;Medical College of Nanchang University;  

OBJECTIVE:To establish a method for quantitative analysis of 7 kinds of bacterial inhibitors and quantitative determination of 4 kinds of bacterial inhibitors to check whether the types and content of bacterial inhibitors in Timolol maleate eye drops(TMED)are in agreement with the formulation.METHODS:The samples were 85 batches of TMED from 15 manufacturers.With the qualitative basis of retention time and diode array detector(DAD)spectrum,HPLC-DAD method was adopted for qualitative analysis of 7 kinds of bacterial inhibitors in samples,such as sorbic acid,thiomersalate,methylparaben,ethylparaben,propylparaben,butylparaben and benzalkonium bromide.HPLC method was also conducted for quantitative determination of ethylparaben and benzalkonium bromide of samples,and atomic fluorescence spectrometry(AFS)was detected for thiomersalate and phenylmercuric acetate of samples.RESULTS:The qualitative analysis results showed that the types of bacterial inhibitors in 85 batches of TMED were all in agreement with the formulation.The quantitative determination results showed that the bacterial inhibitors content in ±20% of formulation was limit gauge.The unqualified rate of the samples and enterprises were 15.2% and 53.8%,respectively.CONCLUSIONS:The developed method is suitable for the quality control of the bacterial inhibitors in TMED.It is suggested that set content check of bacterial inhibitors in the quality standard of TMED.

【CateGory Index】： R927.11

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