两面针镇痛分散片的溶出度测定方法研究

Determination of the Dissolution of Nitidine Chloride in Liangmianzhen Zhentong Dispersible Tablets

关键词:  两面针镇痛分散片  高效液相色谱法  溶出度测定  氯化两面针碱

Key words:  Liangmianzhen Zhentong Dispersible tablets  HPLC  determination of dissolution  nitidine chloride

摘要:

目的 建立两面针镇痛分散片溶出度的测定方法。方法 采用浆法、转速为50 r·min^-1，介质900 mL，测定溶出曲线。色谱条件：C₁₈色谱柱，流动相为乙腈-0.02mol·L^-1磷酸二氢钾溶液(32∶68)，检测波长为328 nm，流速为1 mL·min^-1，柱温为30 ℃，进样量是100 μL。结果 采用pH 6.8磷酸盐溶液为两面针镇痛分散片的溶出度测定介质时，氯化两面针碱在1.562~18.744 μg·mL^-1(r=0.999 7)内与峰面积有良好的线性关系。结论 本方法简便、准确、专属性强、回收率高，可用于该制剂的质量控制。

Abstract:

OBJECTIVE To establish a methodology for the determination of the dissolution of nitidine chloride in Liangmianzhen Zhentong Dispersible tablets. METHODS Dissolution curves were generated by use of slurry, at speed of 50 r·min^-1 and volume of 900 mL for medium. HPLC was performed on a C₁₈ column using acetonitrile-0.02 mol·L^-1 potassium dihydrogen phosphate solution (32∶68) as the mobile phase at a flow rate of 1 mL·min^-1. The detection wavelength was 328 nm. The column temperature was 30 ℃ and the inject volume was 100 μL. RESULTS The linear range of nitidine chloride was 1.562-18.744 μg·mL^-1(r=0.999 7), with pH 6.8 phosphate solution as dissolution medium in the measurement. CONCLUSION The methodology is simple, accurate, specific, and of high recovery rate. It is applicable for the quality control in preparing Liangmianzhen Zhentong Dispersible tablets.