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HPLC测定罗红霉素软胶囊的溶出度
引用本文:张传学,王建. HPLC测定罗红霉素软胶囊的溶出度[J]. 中国现代应用药学, 2013, 30(3): 303-306
作者姓名:张传学  王建
作者单位:浙江省武义县第一人民医院药剂科,浙江 武义 321200;浙江省食品药品检验研究院,杭州 310004
基金项目:国家药典委员会国家药品标准提高研究项目(国药典化发[2010]84号)
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。

关 键 词:罗红霉素软胶囊;溶出度;高效液相色谱法
收稿时间:2012-07-26
修稿时间:2012-12-10

Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC
ZHANG Chuanxue and WANG Jian. Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC[J]. The Chinese Journal of Modern Applied Pharmacy, 2013, 30(3): 303-306
Authors:ZHANG Chuanxue and WANG Jian
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.
Keywords:roxithromycin soft capsules   dissolution   HPLC
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