摘要
目的测定盐酸左旋沙丁胺醇缓释胶囊的有关物质。方法采用反相高效液相色谱法(RP-HPLC法),色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),以甲醇-磷酸盐缓冲液(取磷酸二氢钠9.77 g,加水溶解并稀释至1 000 mL,用磷酸调节pH值至3.10±0.05)(体积比20∶80)为流动相,检测波长为224 nm,流速1.0 mL.min-1。结果各杂质峰分离良好,左旋沙丁胺醇的最低检测限为14 ng。结论本法可用于盐酸左旋沙丁胺醇缓释胶囊中有关物质的检测。
Objective To establish an HPLC method for analyzing levalbuterol hydrochloride sustained- release capsules. Methods Samples were analyzed on a Kromasil-column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-PBS (9. 77 g sodium dihydrogen phosphate in 1 L of water, adjusted to pH 3.10 ± 0.05 with phosphoric acid) (20:80). The detection wavelength was 224 nm and the flow rate l. 0 mL · min^-1. Results Impurities were separated well from each other, and the detection limit of levalbuterol hydrochloride was 14 ng. Conclusion This method is suitable for the quality of levalbuterol hydrochloride sustained-release capsules.
出处
《广东药学院学报》
CAS
2009年第1期49-51,共3页
Academic Journal of Guangdong College of Pharmacy
基金
2006年广州市科技计划项目(2006Z3-E406)