RP-HPLC法测定复方盐酸普莫卡因乳膏中盐酸普莫卡因的含量

目的 测定复方盐酸普莫卡因乳膏中盐酸普莫卡因得含量。方法采用RP—HPLC法测定复方盐酸普莫卡因乳膏中盐酸普莫卡因得含量。色谱柱：CLC—ODS（4．6×150mm，5μm），流动相：乙腈-pH7．5磷酸盐缓冲液（55：45），柱温：40℃，流速：1．5ml／min，检测波长：224nm，进样量：20μL。结果盐酸普莫卡因在0．2—0．9mg／ml浓度范围内线性关系良好，其平均回收率为99．6％，RSD值为0．53％，制剂中其他成分及辅料对含量测定无干扰。结论该含量测定法准确简便，专属性强，重现性及稳定性良好，适用于复方盐酸普莫卡因乳膏的质量控制。

Determination of Pramoxine Hydrochloride in Compound Pramoxine Hydrochloride Cream by RP-HPLC

Objective To determine Pramoxine Hydrochloride in Compound Pramoxine Hydrochloride Cream. Methods Pramoxine Hydrochloride in Compound Pramoxine Hydroehloride Cream was determined by RP-HPLC. An CLC-ODS C18 Column （ 4. 6 ×150 mm, 5μm ） under the temperature of 40 C, and aeetonitrile - pH 7. 5 phosphate buffer （ 55 ： 45 ） as the mobile phase were used at a flow rate of 1.5 ml / min, with a detection wavelength of 224 nm, and an injection volume of 20 μL. Results The linear range for Pramoxine was 0.2 - 0.9 mg / ml ; the average recovery was 99. 6% with RSD value was 0. 53 % , in preparation Other components and aecessories in the cream had non-interferenee with the determination. Conclusion The accurate determination is simple, specific, stable and reproducible, whieh is applicable for the quality control of Pramoxine hydrochloride cream.