摘要
目的建立测定盐酸氨溴索口腔崩解片中主药含量及其有关物质检查的方法.方法采用HPLC法,用Hypersil C18柱,甲醇-20 mmol·L-1磷酸二氢钠-三乙胺(50∶50∶0.1, 磷酸调pH 3.60±0.1)为流动相,检测波长244 nm,流速1.0 ml·min-1.结果盐酸氨溴索在2.5～60.0 μg·ml-1范围内,峰面积与浓度的线性关系良好(r=0.9999),高、中、低浓度的平均回收率为100.9%～103.2%, RSD为0.67%～1.09%.结论所用方法准确、简便、快速,适用于盐酸氨溴索口腔崩解片的质量控制.
OBJECTIVE To establish a method for determination of the contents and related substances in Ambroxol hydrochloride orallydisintegrating tablet. METHODS HPLC method was adopted with a Hypersil Cls column （250 mm× 4.6 mm, 10 μm）, and the mobile phase consisted of methyl alcohol - 20 mmol· L^-1 NaH2PO4 - triethylamine （50： 50： 0.1, adjusted to pH 3.60 ± 0.1 with phosphoric acid）. The UV detection was at 244 nm and the flow rate was 1. 0 ml·min^- 1. RESULTS The calibration curve was linear（ r = 0,9999） within the range of 2.5 - 60.0 μg· ml^-1 for Ambroxol hydrochloride. The average recovery was from 100.9% to 103.2% for three different levels of the amount of Ambroxol hydrochloride, with RSD was from 0.67 % to 1.09 %. CONCLUSION This method is simple, rapid, accurate and effective for testing content and related substances in Ambroxol hydrochloride orallydisintegrating tablet. Tiffs method is suitable for the quality control of Ambroxol hydrochloride orallydisintegrating tablets.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2005年第6期538-540,共3页
West China Journal of Pharmaceutical Sciences
