盐酸林可霉素滴眼液含量测定方法的改进

Improvement the Content Determination Method for Lincomycin Hydrochloride Eye Drops

目的:对盐酸林可霉素滴眼液含量测定方法进行改进,现行方法对林可霉素峰与羟苯乙酯峰难以分开,对林可霉素含量测定干扰很大;方法:本法改为ODS Hypors C_(18)柱(200 mm×4.6mm,5μm)、流动相:0.05 mol·L^(-1)硼沙溶液(用85%磷酸溶液调节pH至6.0)-甲醇-乙腈(53:40:7),检测波长214nm,流速1.0ml·min^(-1)。结果:本法平均回收率为99.5%、RSD为0.6%,改进后的方法排除了羟苯乙酯的干扰。结论:改进后的方法准确、可靠。

Objective： To improve the content determination method for lincomycin hydrochloride eye drops, It was assay according to National Chemical Drug standard No. 5, but the peak of lincomycin hydrochloride and that of ethyl hydroxybenzoate could not be separated, the ethyl hydroxybenzoate interfere the content determination greatly. Method： The improvement method was analyzed by HPLC on a column of hypersil ODS C18 （200 mm × 4.6 mm,5 μm）with 0.05 mol. L^-1 borax solution（ adjust pH to 6.0 with 85% phosphoric acid）-methanol-acetonitrile（53： 40：7 ）as mobile phase, the detection wavelength was 214 nm, the flow rate was 1.0 ml· min^-1. Result： The average recovery was 99.5% with RSD 0.6% （n = 5） ,the improvement method overcome the interference of ethyl hydroxybenzoate. Conclusion： The improved method is accurate and reliable.