HPLC测定罗红霉素软胶囊的溶出度

Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC

摘要: 目的采用HPLC测定罗红霉素软胶囊的溶出度。方法以醋酸盐缓冲液(pH 5.5)为溶出介质，桨法，转速为100 r·min^-1，60 min时取样，取样后采用HPLC测定。结果罗红霉素在0.02~ 0.2 mg·mL^-1内呈良好的线性关系(r=0.999 9)，罗红霉素软胶囊的平均回收率为100.1％(RSD=0.6%)，溶出液稳定，3批软胶囊在60 min时平均溶出度均在75%以上并且有较好的均一性。结论该法可用于罗红霉素软胶囊溶出度的测定。

Abstract: OBJECTIVE To determine the dissolution of roxithromycin soft capsules by HPLC. METHODS The dissolution medium was acetate buffer (pH 5.5). Apparatus 2 was used with 100 r·min^-1. The dissolution medium was taken and analyzed by HPLC at 60 minutes. RESULTS It showed that the standard curve was linear in the range of 0.02-0.2 mg·mL^-1(r=0.999 9). The average recovery was 100.1%(RSD=0.6%) for roxithromycin soft capsules. The dissolutions of soft capsules from three batches were over 75%. CONCLUSION The established method can be used for determination of roxithromycin soft capsules dissolution.