HPLC同时测定复方替米沙坦片中主成分含量

Simultaneous Determination of Main Components in Compound Telmisartan Tablets by HPLC

目的:建立复方替米沙坦片中两种药物含量测定的HPLC法。方法:采用菲罗门Cia色谱柱(150 mm×4.6 mm,5Rm),以50 mmol·L^(-1)磷酸二氢钠溶液(pH 6.0,0.5%三乙胺)-乙腈(40:60,v/v)为流动相,流速1.0 ml·min^(-1),测波长254 nm,柱温30℃进样量20μl。结果:替米沙坦与苯磺酸氨氯地平可达到较好分离潜米沙坦的质量浓度在4.0~80.0μg·ml^(-1)内(r=0.9999),苯磺酸氨氯地平质量浓度在1.0-20.0μg·ml^(-1)(r=0.999 9)内与峰面积呈良好的线性关系。替米沙坦和苯磺酸氨氯地平的平均回收率分别为99.90%和100.52%(n=9),RSD分别为0.74%和1.48%(n=9)。结论:该方法专属性强、稳定准确适用于复方替米沙坦片的含量测定。

Objective： To establish an HPLC method for the simultaneous determination of telmisartan and amlodipine besylate in tablets. Methods： The isocratic separation was achieved on a Phenomenex C18 column （150 mm× 4.6 mm, 5 μm） with the mobile phase composed of 50 mmol L-1 sodium dihydrogen phosphate buffer （ pH 6.0, 0.5% triethylamine） -acetonitrile （40： 60, v/v）. The flow rate was 1.0 ml min - 1 , the detection wavelength was 254 nm, the column temperature was 30℃ and the sample size was 20 μl. Results： Telmisartan could be well separated from amlodipine besylate under the conditions mentioned above. The linearity be- tween the peak area and the concentration was obtained within the range of 4.0-80.0 μg ml - 1 （ r = 0.999 9 ） for telmisartan and 1.0- 20.0 μg ml- 1 （r = 0.999 9） for amlodipine besylate. The mean recovery of telmisartan and amlodipine besylate was 99.90% and 100.52%, and RSD was 0.74% and 1.48%, respectively （ n = 9）. Conclusion ： The method is specific, stable and accurate in the determination of compound telmisartan tablets.