HPLC法同时测定氯霉素醋酸曲安奈德乳膏中两组分含量

Simultaneous Determination of Triamcinolone Acetonide Acetate and Chloramphenicol in Chloramphenicol and Triamcinolone Acetonide Acetate Cream by HPLC-DAD

目的:建立HPLC法测定氯霉素醋酸曲安奈德乳膏中氯霉素和醋酸曲安奈德的含量。方法:使用ZORBAX SB-C_(18)(250mm×4.6 mm,5μm)色谱柱,以甲醇:p H 3.0磷酸盐缓冲液为流动相,梯度洗脱,流速:1.0 ml·min^(-1),检测波长:240 nm,柱温:室温,进样量:20μl。结果:醋酸曲安奈德在6.12~48.96μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9);平均回收率为99.7%,RSD=1.3%(n=9)。氯霉素在62.1~745.2μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9);平均回收率为99.4%,RSD=1.0%(n=9)。结论:本法灵敏、准确、专属性强,可用于氯霉素醋酸曲安奈德乳膏的质量控制。

Objective： To establish an HPLC method for the simultaneous determination of triamcinolone acetonide acetonide（TAA）and chloramphenicol in the cream. Methods： The chromatographic system consisted of a ZORBAX SB-C_（18）column（250 mm × 4. 6 mm,5μm）. The mobile phase consisted of methanol and phosphate buffer with gradient elution at a flow rate of 1. 0 ml·min（-1）,the detection wavelength was 240 nm,the column temperature was ambient,and the sample size was 20 μl. Results： The calibration curve was linear for TAA and chloramphenicol within the concentration range of 6. 12-48. 96 μg·ml（-1）and 62. 1-745. 2 μg·ml（-1）with the recovery of99. 7%（ RSD = 1. 3%,n = 9） and 99. 4%（ RSD = 1. 0%,n = 9）,respectively. Conclusion： The method is sensitive,accurate and specific,and can be used to control the quality of chloramphenicol and triamcinolone acetonide acetate cream.