异福胶囊溶出度测定方法的建立

Establishment of Method for Dissolution Test of Rifampin and Isoniazid Capsules

目的建立异福胶囊溶出度测定方法。方法采用转篮法,以0.1moL·L-1盐酸溶液为溶剂,转速为100r.min-1,45min时取样。以紫外可见-分光光度法测定利福平的溶出度,检测波长为474nm;以HPLC法,采用Water公司生产的十八烷基硅烷键合硅胶色谱柱,测定异烟肼的溶出度,以水-磷酸盐缓冲液-甲醇(850∶100∶50)为流动相,检测波长为254nm,流速为1.5mL.min-1。结果利福平在12.61～51.91μg·mL-1的浓度范围内,线性关系良好。利福平平均回收率为99.8%(RSD=0.14%,n=12);异烟肼的进样量在0.3245～1.3335μg的范围内,线性关系良好。异烟肼平均回收率为99.6%(RSD=0.51%,n=12)。结论本方法操作简便,结果正确,为完善异福胶囊的质量标准提供有效手段。

Objective To establish the method for dissolution test of Rifampin and Isoniazid Capsules. Methods The apparatus was used with bastet method and with 0.1moL·L^-1 hydrochloric acid as dissolution medium at a rotate speed of 100r·min^-1. According to the UV method,the absorbance of rifampin which was dissolved from its capsules in 45 minutes was determined at the wavelength of maximum absorbance about 474nm. According to the HPLC method for determining isoniazid which was dissolved from its capsules in 45 minutes,the dissolution relation were taken and analyzed by HPLC method. A C18column was used with mobile phase consisted of a mixture of water,phosphate buffer solution and methanol（850：100：50）. The wavelength used for detection was 254nm. The flow rate was about 1.5mL·min^-1. Results The linear range of rifampin was 12.61～51.91μg·mL-1. The satisfactory recoveries were obtained：rifampin was 99.8%（RSD=0.14%,n=12）. The linear range of isoniazid was 0.3245～1.3335μg. The satisfactory recoveries were obtained：isoniazid was 99.6%（RSD=0.51%,n=12）. Conclusion The method is rapid,convenient,accurate and reliable. It can be used as a reliable method of quality control for Rifampin and Isoniazid Capsules.