| 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. |
| ZHANG Chuanxue,WANG Jian .Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(3):303-306. |
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| 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 |
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| 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) |
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| Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC |
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ZHANG Chuanxue1, WANG Jian 2
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1.Department of Pharmacy, the First People’s Hospital of Wuyi, Wuyi 321200, China;2.Zhejiang Institute for Drug Control, Hangzhou 310004, China
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| 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. |
| Key words: roxithromycin soft capsules dissolution HPLC |
