甲磺酸帕珠沙星滴眼液中抑菌剂含量的考察

Quantitation detection of ethyl 4-hydroxybenzoate in pazufloxacin mesilate eye drops

目的建立测定甲磺酸帕珠沙星滴眼液中抑菌剂羟苯乙酯含量的高效液相色谱法,并用于考察不同批次样品中抑菌剂羟苯乙酯的含量。方法以甲醇为溶剂配制相关溶液,采用以十八烷基硅烷键合硅胶为填充剂的色谱柱,以甲醇-0. 02 mol/L磷酸二氢钠溶液(50∶50)为流动相,流速为1. 0 ml/min,进样量为10μl,检测波长为256 nm。结果羟苯乙酯的线性范围为0. 31 mg/L～311. 6 mg/L(r=1. 000 0),定量限浓度为0. 08 mg/L(S/N=9. 9),平均回收率为99. 3%。结论经方法学验证,本文研究所建立的方法简便、灵敏、准确;测定结果显示不同批次样品中抑菌剂羟苯乙酯的含量波动在20%左右。

Objective A high performance liquid chromatography( HPLC) method was developed to determine the content of ethyl 4-hydroxybenzoate in pazufloxacin mesilate eye drops. It was used to investigate the content of ethyl 4-hydroxybenzoate in different batches of samples. Methods The related solutions were prepared with methanol. The HPLC method was carried out with a C18 column. The mobile phase was methanol-phosphate buffer( 50∶50,V/V). The flow rate was 1. 0 ml/min. The injection volume was 10 μl. The detection wavelength was set at 256 nm. Results The linear range of ethyl 4-hydroxybenzoate was 0. 31 mg/L-311. 6 mg/L( r = 1. 000 0). The limit of quantification was 0. 08 mg/L( S/N = 9. 9). The average recovery of ethyl 4-hydroxy benzoate was 99. 3%. Conclusion The established method is simple,sensitive. The content of ethyl4-hydroxybenzoate is around 20% in different batches of samples fluctuates.