HPLC法检查更昔洛韦眼用凝胶中的有关物质

Determination of related substances in ganciclovir ophthalmic gel by HPLC

目的建立用于更昔洛韦眼用凝胶有关物质测定的HPLC法,为建立更昔洛韦眼用凝胶的质量控制标准提供依据。方法采用高效液相色谱法,甲醇-水(体积比3∶97)为流动相A,甲醇为流动相B,梯度洗脱,柱温:35℃,检测波长:252 nm,流速:1.0 mL·min^(-1),进样量:40μL。结果更昔洛韦与相邻杂质峰及杂质间峰均能达到完全分离;更昔洛韦及杂质A、B、C、E、F分别在0.0303~1.5150、0.0297~1.4843、0.0302~1.5106、0.0303~1.5140、0.0276~1.3806、0.0319~1.5965 mg·L^(-1)浓度范围内与各自峰面积呈现良好的线性关系;杂质A、B、C、E和F的回收率均在97.1%~98.7%之间,RSD值均小于2.0%。结论建立的方法可用于更昔洛韦眼用凝胶中的有关物质测定。

Objective To establish an HPLC method for determination of related substances in ganciclovir ophthalmic gel for evaluating the quality of ganciclovir ophthalmic gel.Methods The HPLC method was performed with gradient elution by the mobile phase A consisting of methanol-water(V∶V=3∶97)and the mobile phase B of methanol.The test was performed at the wavelength of 252 nm,the flow rate was 1.0 mL·min^(-1),the column temperature was maintained at 35℃,and the injection volume was 40μL.Results Ganciclovir could be completely separated from adjacent impurities and impurities;Ganciclovir and the impurities A,B,C,E and F had good linear relationships with the peak area at 0.0303-1.5150,0.0297-1.4843,0.0302-1.5106,0.0303-1.5140,0.0276-1.3806,0.0319-1.5965 mg·L^(-1);The average recoveries of A,B,C,E and F were at the range of 97.1%-98.7%,RSD≤2.0%.Conclusion The method can be used to determine the related substances in ganciclovir ophthalmic gel.