HPLC法同时测定菌克软膏盐酸林可霉素和硝酸咪康唑的含量

Determination of Lincomycin Hydrochloride and Miconazole Nitrate in Junke Cream by HPLC

目的 建立高效液相色谱法同时测定菌克软膏中盐酸林可霉素和硝酸咪康唑的含量。方法 采用高效液相色谱法 ,HYPERSIL -CN色谱柱 (5 μm ,4 .6mm× 2 0 0mm) ,流动相 0 .0 5mol·L-1硼砂溶液 (用磷酸调节pH至 6 .0 ) -甲醇 (85∶15 ) ,流速 1.0ml/min ;检测波长 2 14nm ;进样量 10 μl。 结果 盐酸林可霉素在 0 .0 8～ 3.2mg·ml-1浓度范围内均呈良好的线性关系 ,r =0 .9999(n =5 ) ,硝酸咪康唑在 0 .0 8～ 1.6mg·ml-1范围内呈良好的线性关系 ,r =0 .9993(n =5 )。盐酸林可霉素的平均回收率为 10 1.2 3% ,RSD为 0 .93% ,硝酸咪康唑的平均回收率为 99.82 % ,RSD为 0 .5 7%。结论 本方法分离度好 ,简便 ,准确 ,适用于软膏制剂中 2组分的同时测定 ,可作为产品的质量控制方法。

Aim To establish a method for determination of lincomycin hydrochloricde and miconazole nitrate in JunKe Cream simultaneously.Methods A HPLC method with chromatographic conditions included HYPERSIL-CN column(5um,4.6mm×200mm) and the mobile phase consisted of 0.05mol·L -1 lsodium borste (adjust with phosphoric acid to a pH of 6.0)-methanol(85∶15) was used.The detection wavelength was 214nm,the flow rate was 1.0ml/min,the injection volume was 10μl.Results Lincomycin hydrochloride had a good linearity(r=0.999 9) in the range of 0.08～3.2mg·ml -1 ,its average recovery was 101.23%(RSD=0.93%,n=5).Minconazole nitrate had a good linearity (r=0.999 3) in the range of 0.08～1.6mg·ml -1 ,its average recovery was 99.82% (RSD=0.57%,n=5).Conclusion The method was simple,sensitive and accurate for simultaneous determination of the two constituents in JunKe Cream.