Simultaneous Determination of Main Components in Compound Telmisartan Tablets by HPLC / 中国药师

ABSTRACT

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 (4060, 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 20μl. 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.