中国药房2011，Vol.22Issue(4)：371-373,3.
HPLC法测定阿奇霉素干混悬剂的有关物质
Determination of Related Substances of Azithromycin Suspension by HPLC
摘要
Abstract
OBJECTIVE: To establish a method for the determination of the related substances of Azithromycin suspension.METHODS: HPLC was adopted using Venusil XBP-C18 as column. The mobile phase consisted of 0.05 mol· L-1 dibasicsodium phosphate buffer solution (pH value adjusted to 8.2 by 20％ phosphoric acid)-acetonitrile (47: 53). The injection volume was 20 μ L and the flow rate was 1.2 mL·min-1. UV detection wavelength was set at 210 nm. RESULTS: The resolution was 1.92 after experimental light damage, and it was 2.16 after heat damage test. After treated with acid, resolution of sample was 1.76, and it was 7.88 and 2.11 in alkali destruction test and oxidative damage test. The related substances were 2.41％, 2.45％ and 2.43％. CONCLUSION: The method is simple, sensitive and accurate for the determination of the related substances of Azithromycin suspension.关键词
高效液相色谱法/阿奇霉素干混悬剂/破坏试验/有关物质分类
医药卫生引用本文复制引用
吴燕,刘园,徐荣..HPLC法测定阿奇霉素干混悬剂的有关物质[J].中国药房,2011,22(4):371-373,3.
