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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 a HPLC method for the determination of two drugs in compound telmisartan tablets. Methods: Phenomenex Cia column (150 mm × 4.6 mm, 5Rm) was used in 50 mmol·L -1 sodium dihydrogen phosphate solution (pH 6.0, 0.5% triethylamine) -acetonitrile (40:60 , v / v) as the mobile phase at a flow rate of 1.0 ml · min -1 with a detection wavelength of 254 nm and a column temperature of 30 ℃. Results: The concentration of telmisartan and amlodipine besylate could be separated well in the range of 4.0 ~ 80.0μg · ml ~ (-1) (r = 0.9999), amlodipine besylate The mass concentration ranged from 1.0 to 20.0 μg · ml -1 (r = 0.999 9) and the peak area showed a good linear relationship. The average recoveries of telmisartan and amlodipine besylate were 99.90% and 100.52% (n = 9), respectively, with RSDs of 0.74% and 1.48%, respectively (n = 9). Conclusion: The method is specific, stable and accurate for the determination of compound telmisartan tablets.