HPLC法测定苹果酸阿莫曲坦含量的研究

Determination of Almotriptan Malate Tablets by HPLC

[目的]建立一种高效液相色谱法,测定苹果酸阿莫曲坦片的含量.[方法]采用高效液相色谱法（HPLC）,色谱柱为Agilent ZobaxSB C8 column（250×4.6mm,5μm）;以缓冲液（取0.5g辛烷磺酸钠与5ml磷酸溶液,加水至1 000 ml,用5mol/L氢氧化钠调节pH至3.0）-乙腈作为流动相,等度洗脱,流速1.0 ml/min,柱温30℃,检测波长230 nm,选样量10μl.[结果]苹果酸阿莫曲坦的浓度在17.49～209.88 μg/ml范围内线性关系良好（Y=27.534X＋9.693,r =0.999 9）,高、中、低3种浓度的平均回收率（n=3）为99.23％（RSD=0.95％）;中间精密度RSD =0.98％ （n =6）,重复性和耐用性良好.[结论]该方法简便、灵敏、准确,可作为苹果酸阿莫曲坦片含量的检验方法.

[ Objecive ] To establish a HPLC method for the determination of almotriptan malate tablets. [ Method ] Using high-performance liquid chromatography, chromatographic column of Agilent zobax SB C8 column （250 ×4.6 mm, 5 μm） ; With a mixture of octane sulfonate buffer （adjusted pH to 3.0 with phosphoric acid） and acetonitrile as mobile phase, isocratic elution method, flow rate 1.0 ml/min, tempera- ture 30℃, detection wavelength 230 nm, injection 10 μl. [ Result ] Almotriptan malate concentration in the range of 17.49 to 209.88 μg/ml has a good linear relationship （ Y = 27. 534X ＋ 9. 693, r = 0.999 9）, the average recovery of high, middle, low, 3 kinds of concentration ratio （ n = 3 ） 99.23 % （ RSD = 0.95 % ） ; intermediate precision RSD = 0.98 % （ n = 6）, Repeatability and durability is good. [ Conclusion ] The method is simple, sensitive, accurate, reproducible, which is suitable for the determination of almotriptan malate.