曲咪新乳膏中醋酸曲安奈德有关物质检查方法研究

Determination of related substances of triamcinolone acetonide in triamcinolone acetonide acetate and miconazole nitrate and neomycin sulfate cream

目的建立高效液相色谱(HPLC)法测定曲咪新乳膏中醋酸曲安奈德的有关物质。方法使用YMC Triart C18(4.6 mm×200 mm,5μm)色谱柱,以水(A)-乙腈(B)为流动相,梯度洗脱;流速1.0 ml/min;检测波长240 nm,柱温30℃,以对照品对照法对醋酸曲安奈德进行定量控制,其他杂质作限度检查。结果在建立的色谱条件下,醋酸曲安奈德主成分色谱峰与相关的杂质完全分离,制剂中的辅料对主成分及有关物质测定无干扰,测定6批制剂最大单个杂质含量为0.21%~0.51%,均<1.0%;杂质总量为0.84%~1.25%,均<2.5%,醋酸曲安奈德有关物质均符合规定。结论所建立的方法专属性强、重复性好,可用于曲咪新乳膏中醋酸曲安奈德有关物质的检查。

Objective To establish an HPLC method for the determination of the related substances of triamcinolone acetonide acetate(TAA) in Triamcinolone Acetonide Acetate and Miconazole Nitrate and Neomycin Sulfate Cream.Methods YMC Triart C18 column(4.6 mm×200 mm,5 μm) was used,the mobile phase consisted of water(A)and acetonitrile(B)in gradient elution manner,the flow rate was 1.0 ml/min,the column temperature was 30℃ and the detection wavelength was240 nm.TAA was quantitatively controlled by the control method.Other impurities were examined to the limit.Results Under the proposed chromatographic conditions,the principal component chromatographic peak of TAA and the related substances were separated completely,and the auxiliary material in the cream did not interfere in the determination of principal component and related substances.The determination results of the six batches of preparations showed that the maximum single unknown impurity ranged from 0.21% to 0.51%,all less than 1.0%,the total impurities ranged from0.84% to 1.25%,all less than 2.5%.The related substances of TAA substances were meet the specification.Conclusion The method is proved that it has good sensitivity and specificity,and it is suitable for the quality control of Triamsin cream.