HPLC内标法测定曲安奈德新霉素贴膏中醋酸曲安奈德的含量

Determination of Triamcinolone Acetonide Acetate in Triamcinolone Acetonide and Neomycin Paste by HPLC Internal Standard Method

目的:建立曲安奈德新霉素贴膏中醋酸曲安奈德的含量测定方法。方法:通过正辛烷溶解膏体,90%乙醇萃取的方法,提取贴膏剂中的醋酸曲安奈德,建立高效液相色谱法,以炔诺酮为内标,色谱条件为:采用CAPCELL PAK C18 MGⅡ色谱柱(4.6 mm×250 mm,5μm),以甲醇为流动相A,水为流动相B,进行梯度洗脱,检测波长为240 nm,流速1.0 mL/min,柱温30℃,进样量20μL。结果:醋酸曲安奈德在4~40μg/mL内线性关系良好(r=0.9990);平均回收率为99.4%(n=9,相对标准偏差RSD=0.7%)。结论:方法准确、可靠,可作为曲安奈德新霉素贴膏中醋酸曲安奈德的含量测定方法。

Objective:To establish a method for the determination of triamcinolone acetonide acetate in triamcinolone acetonide and neomycin paste.Methods:Dissolve the paste by n-octane and then extract the triamcinolone acetonide acetate from the paste by 90%ethanol.A HPLC method was established with norethindrone as the internal standard on a CAPCELL PAK C18 MGⅡcolumn(4.6 mm×250 mm,5μm).Methanol was used as mobile phase A,water was used as mobile phase B with gradient elution.The detection wavelength was 240 nm,the flow rate was 1.0 mL/min,the column temperature was 30℃and the injection volumn was 20μL.Results:The linear ranges of triamcinolone acetonide acetate was 4~40μg/mL(r=0.9990),the average recovery was 99.4%(n=9,RSD=0.7%).Conclusion:The method is accurate and reliable,can be used as a method for the determination of triamcinolone acetonide acetate in triamcinolone acetonide neomycin plaste.