张 雁，孙映求，王兰, 胡翮（湘潭市药品检验所  湖南  湘潭  411100）

[摘要]目的：建立RP-HPLC法测定克霉唑含量的高效液相色谱法。方法：以十八烷基键合硅胶为填充剂，甲醇-磷酸氢二钾溶液（3∶1）[1]为流动相，(磷酸氢二钾溶液：取磷酸氢二钾4.35g以水稀释至1000ml)，流速约为1.0ml•min-1,检测波长为260nm。结果：克霉唑在0.14 mg•ml-1~0.26 mg•ml-1的浓度范围内线性关系良好（r=0.9990）。克霉唑溶液的平均回收率为100.9%。结论：该法快速、简单、准确，可作为该制剂的质量控制方法。

[关键词] 反相高效液相色谱法；克霉唑。

Determination of the Content of Clotrimazole in Clotrimazole Solution by RP-HPLC

Zhang Yan, Sun Yingqiu, Wang Lan, Hu He (Xiangtan Institute for Drug Control, Hunan, Xiangtan, 411100)

ABSTRACT Objective: To establish RP-HPLC method for determining the content of clotrimazole. Method: The assay  was conducted on a Kromasil ODS-1 HPLC coulumn (C18, 250 ╳ 4.6mm) with methanol and dibasic potassium phosphate solution (3∶1)[1] as mobile phase(Dibasic potassium phosphate solution was made by dissolving 4.35g of dibasic potassium phosphate  in water to make 1000 ml of  solution.） The  detection wavelength was 260 nm. Result: The calibration curve was linear in the range of 0.14 mg•ml-1 to 0.26 mg•ml-1 (r=0.9990) for clotrimazole. The average recovery of clotrimazole was 100.9% for clotrimazole solution. Conclusion: This method is rapid, simple, accurate and suitable for the quality control of this preparation.

KEY WORDS: RP-HPLC; clotrimazole.