HPLC法测定醋酸曲安奈德薄荷软膏中醋酸曲安奈德的含量(1)
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[摘要] 目的 建立用高效液相色谱法测定醋酸曲安奈德薄荷软膏中醋酸曲安奈德的含量的方法。 方法 采用Diamonsil C18色谱柱(250 mm × 4.6 mm，粒直径5 μm)；流动相：甲醇-水(60:40)；流速：1.0 mL/min；柱温：25℃；检测波长：240 nm。 结果 醋酸曲安奈德在40～200 μg/mL范围内线性关系良好，r = 0.999 9，平均回收率为99.6%，RSD = 0.3(n = 6)。 结论 本法操作简便，精密度好，结果准确可靠，适用于醋酸曲安奈德薄荷软膏的质量控制。
[关键词] 醋酸曲安奈德薄荷软膏；醋酸曲安奈德；高效液相色谱法；含量测定
[中图分类号] R92 [文献标识码] A [文章编号] 1674-4721(2012)07(a)-0079-03
Determination of triamcinolone acetonide acetate in Triamcinolone acetonide acetate menthol ointment by HPLC
ZHONG Xiaoyan
Department of Drug Manufacturing Room, Chronic disease prevention and control the Hospital of Qingyuan city in Guangdong Province, Qingyuan 511515, China
[Abstract] Objective To establish an HPLC method for determination of triamcinolone acetonide acetate in Triamcinolone acetonide acetate menthol ointment. Methods The analysis was performed on a Diamonsil C18 (250 mm×4.6 mm, 5 μm) column; The mobile phase was methanol-water (60:40) at a flow rate of 1.0 mL/min; The detective wavelength was 240 nm and the column temperature was 25℃. Results The linear range of riamcinolone acetonide acetate was 40-200 μg/mL(r = 0.999 9), with average recovery of 99.6% and RSD = 0.3 (n = 6). Conclusion The method is accurate, reliable, specific and can be used for the quality control of the Triamcinolone acetonide acetate menthol ointment.
[Key words] Triamcinolone acetonide acetate menthol ointment; Triamcinolone acetonide acetate; HPLC; content determination
醋酸曲安奈德薄荷软膏是清远市慢性病防治医院的医院自制制剂，是一种外用软膏，具有抗感染和抗过敏作用，临床上常用于治疗神经性皮炎、湿疹、银屑病等。其主要成分为醋酸曲安奈德，目前该医院制剂的质量标准尚无含量测定的项目。《中华人民共和国药典》2005年版[1]采用高效液相色谱法的内标法来测定醋酸曲安奈德乳膏中醋酸曲安奈德的含量。该法需要加内标物，且过程相对外标法繁琐些。现采用吕红等[2]介绍的高效液相色谱法测定醋酸曲安奈德薄荷软膏中醋酸曲安奈德的含量，测定方法简便、结果准确、重复性良好，能够有效地控制药品的质量。
1 材料与方法
1.1 仪器
Agilent Technologies 1200型高效液相色谱仪(美国安捷伦科学仪器有限公司) ......
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