胃平分散片中氢氧化铝和溴丙胺太林的含量测定

Determination of Aluminum Hydroxide and Propantheline Bromide in Weiping Dispersible Tablets

目的:建立胃平分散片中氢氧化铝和溴丙胺太林含量的测定方法。方法:用配位滴定法测定氢氧化铝的含量。用HPLC法测定溴丙胺太林的含量,色谱柱:Shim-pack C_(18)(250mm×4.6mm,5μm),流动相:甲醇-磷酸盐缓冲液(60∶40),流速为1.0ml·min^(-1),检测波长为247nm,柱温为30℃。结果:氢氧化铝测定专属性强,平均回收率(以Al_2O_3计)为99.3%,RSD=0.12%(n=6)。溴丙胺太林在30～600μg·ml^(-1)浓度范围内呈良好的线性关系(r=0.999 5),平均回收率为99.3%,RSD=0.23%(n=6)。结论:方法简便、准确、重复性好,可用于该制剂的质量控制。

Objective： To establish a method for determination the contents of aluminum hydroxide and propantheline bromide in Weiping dispersible tablets. Method： The Aluminum Hydroxide was determined by coordination titration . The propantheline bromide was determined by HPLC. The Shim-pack C18 column（250mm ×4.6mm,5μm） was used with menthanol-phosphate buffer saline （60： 40） as mobil phase, the flow rate was 1.0ml· min^- 1, the detection wavelenghth was at 247 nm, and the column temperature was 30℃. Result： The determination of aluminum hydroxide was specific. The average recovery（ counted with A1203 ） was 99.3% and RSD was 0.12 % （n =6）. The linear range of propantheline bromide was 30 - 600μg·ml^-1 （r =0. 999 5）. The average recovery was 99.3% and RSD was 0.23% （n = 6）. Conclusion： The method is sensitive , accurate and reproducible. It can be used for the quality control of Weiping dispersible tablets.