摘要
目的:建立高效液相色谱法测定富马酸卢帕他定片剂含量及有关物质的方法。方法:色谱柱:Dimonsil C_(18)(200 mm×4.6 mm,5μm);流动相:甲醇-2.5 mmol·L^(-1)庚烷磺酸钠溶液(75:25);柱温:30℃;检测波长:247 nm;流速:1.0 ml·min^(-1)。结果:富马酸卢帕他定的线性范围为0.026 6～0.424 8 mg·ml^(-1)(r=0.999 9),平均回收率为100.2%(RSD=0.9%,n=9),片剂中有关物质的含量<1%。结论:建立的方法操作简单、结果准确、专属性强、重复性好,可用于富马酸卢帕他定片剂中有关物质检查及主药含量测定。
Objective： To establish an HPLC method for the quantitative analysis of rupatadine fumaxate and the related substances in rupatadine fumarate tablets. Method： The determination was performed on Dimonsil Cis chromatographic column （200 mm× 4.6 mm,5 μm） at 30 ℃. The mobile phase consisted of methanol - 2. 5 mmol·L-1 sodium heptanesulfonate solution （75：25 ） with the flow rate of 1.0 ml·min ^-1 and the detection wavelength at 247 nm. Result： The method showed a good linear relationship within the range of 0. 026 6-0. 424 g mg·ml^ -1 （ r = 0. 999 9, n = 5 ）. The average recovery was 100. 2% with RSD of 0. 9% （ n = 9 ）. The total content of the related substances in samples was below 1. 0%. Conclusion： The developed method is simple, accurate and reliable, and it can be applied in the determination of rupatadlne fmnarate and the related substances in rupatadine fumarate tablets.
出处
《中国药师》
CAS
2011年第5期664-666,共3页
China Pharmacist
