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

作　　者：瞿发林 [1] 陆健 [2] 章杰兵 [1] 

机构地区：[1]中国人民解放军第102医院,江苏,常州,213003 [2]中国人民解放军,南京军区联勤部药品检验所,江苏,南京,210003

出　　处：《解放军药学学报》2005年第1期58-60,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：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.

关 键 词：硝酸咪康唑 软膏 盐酸林可霉素 HPLC法 含量 高效液相色谱法 同时测定 平均回收率 磷酸 甲醇 

分 类 号：R927.2[医药卫生—药学] R711.31