复方苯佐卡因凝胶质量标准研究

Study on Quality Standard for Compound Benzocaine Gel

目的建立复方苯佐卡因凝胶的质量标准。方法采用高效液相色谱(HPLC)法对制剂中主药苯佐卡因进行有关物质检查和含量测定;色谱条件:C_18柱,流动相:甲醇-0.09%磷酸二氢钾水溶液(磷酸调节pH至3.5)(45∶55),流速:1.0 mL·min^(-1),检测波长290 nm;采用原子吸收分光光度法测定制剂中的氯化锌含量,波长213.8 nm。结果苯佐卡因含量测定在进样浓度6.24~78.0μg·mL^(-1)之间呈良好的线性关系,r=0.999 9,平均回收率为99.2%,RSD=1.36%;苯佐卡因峰与降解产物对氨基苯甲酸峰之间的分离良好;氯化锌含量测定在进样浓度0~2.0μg·mL^(-1)之间呈良好的线性关系,r=0.999 6,回收率为98.3%,RSD=1.86%。结论该方法稳定可靠,专属性强,重复性好,可用于复方苯佐卡因凝胶的质量控制。

To study the quality standard for Compound Benzocaine Gel. METHODS Benzocaine content and its related substances in gel were determined by HPLC. HPLC was applied with a C_18 column with mobile phase comprising of methanol-0.09% potassium dihydrogen phosphate（ 45 ∶55）,the flow rate was 1.0 mL·min^（-1）,and the detection wavelength was 290 nm. Method of AAS was established for the determination of zinc chloride,the detection wavelength was 213.8nm. RESULTS The calibration curve of Benzocaine was linear in the range of 6.24-78.0 μg·mL^（-1）,r= 0.999 9. The average recovery of Benzocaine was 99.2%,RSD= 1.36%.Benzocaine and its related substances（ 4-aminobenzoic acid） were completely separated.The calibration curve of zinc chloride was linear in the range of 0-2.0 μg·mL^（-1）,r = 0.999 6. The average recovery of zinc chloride was98.3%,RSD = 1.86%. CONCLUSION This method is stable,accurate with good reproducibility,can be used for the quality control of Compound Benzocaine Gel.