阿奇霉素胶囊溶出度测定方法的改进

Improved Determination for Dissolution of Azithromycin Capsules

目的:以茜素红荷移分光光度法改进阿奇霉素胶囊溶出度的测定方法。方法:依《中国药典》二部附录XC溶出度测定方法项下第二法,以600mLpH5.0的磷酸盐缓冲液为溶剂,转速为100r·min-1。经45min取样,以茜素红荷移分光光度法在524nm处测定阿奇霉素胶囊的溶出度,限度为75%。结果:阿奇霉素在12.5～62.0mg·mL-1范围内线性关系良好(r=0.9913),平均回收率为100.3%。结论:该方法准确、简便,可用于阿奇霉素胶囊溶出度的测定。

Objective ： To improve the method for the determination of Azithromycin Capsules dissolution based on charge-transfer reaction with Alizarin Red. Methods ：The dissolution test were conducted according to the second method under Appendix X C of Pharmacopoeia of People＇ s Republic of China, using 600 mL phosphate buffer solution with pH 5 as medium, with a stirring speed of 100 r . min^-1. The solution was withdrawn after 45 min, and the absorbance of dissolution solutions was measured at 524 nm. Dissolution limit is 75% of the labeled amount. Result：Good linear correlation was achieved in the range of 12. 5 -62. 0 mg . L ^-1 Azithromycin （r = 0. 991 3 ）. The mean recovery was 100. 3%. Conclusion：The method is accurate, simple, and suitable for the determination of Azithromycin capsules dissolution.