反相高效液相色谱测定氨溴特罗口服溶液中盐酸克仑特罗的研究
Content Determination of Clenbuterol Hydrochloride in Ambroxol Oral Solution by RP-HPLC
陈雁 1肖望书 1李旭2
作者信息
- 1. 扬州职业大学,江苏扬州 225009
- 2. 扬州市第三制药有限公司,江苏扬州 225231
- 折叠
摘要
建立氨溴特罗口服溶液中盐酸克仑特罗成分含量测定的方法并开展方法学验证.采用ZORBAX SB-C18色谱柱,流动相为磷酸二氢钾溶液-甲醇,检测波长244 nm,柱温40℃,流速1.0 mL·min-1,进样量10 μL.结果显示,盐酸克仑特罗在0.0511～0.4099 μg·mL-1范围内线性关系良好;平均回收率(n=9)为100.0079％,RSD为1.57％.测得盐酸克仑特罗含量为标示量的98.96％,符合药典标准.
Abstract
The purpose of the experiment was to establish a method for the determination of clenbuterol hydro-chloride in ambroterol oral solution and to validate the method.The chromatographic column was ZORBAX C18,the mobile phase was monopotassium phosphate solution-Methanol,the detection wavelength was 244 nm,the column temperature was 40 ℃,the flow rate was 1.0 mL/min,and the injection volume was 10 μL.Results showed that clenbuterol hydrochloride had a good linear relationship in the range of 0.0511 µg/mL to 0.4099 µg/mL.The average recovery(n=9)was 100.0022％with the RSD of 1.55％.The content of clenbuterol hydrochloride was 98.96％of the labeled amount,which met the pharmacopoeia standard.
关键词
高效液相色谱法/氨溴特罗口服溶液/盐酸克仑特罗/含量测定Key words
RP-HPLC/Ambroxol oral solution/Clenbuterol hydrochloride/content determination引用本文复制引用
出版年
2024
NETL
NSTL
万方数据