Simultaneous Determination of Two Drugs in Compound Atorvastatin Calcium and Amlodipine Besylate Tablets by HPLC / 中国药师

ABSTRACT

Objective:To establish a method for the determination of atorvastatin and amlodipine in compound atorvastatin calcium and amlodipine besylate tablets. Methods:The determination was performed on a Gemini-NX C18 column (250 mm × 4. 6 mm, 5μm) with the mobile phase consisting of 20 mmol·L-1 potassium dihydrogen phosphate solution ( adjusting pH to 4 with phosphoric acid)-acetonitrile-methanol (30 ∶10 ∶60) at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 240 nm and the column tem-perature was 30℃. The injection volume was 20μl. Results:The linear range of atorvastatine and amlodipine was 0. 4-40. 0μg·ml-1 and 0. 2-20. 0 μg·ml-1, respectively. The mean recovery of atorvastatin and amlodipine was 100. 6% and 99. 7%, and RSD was 0. 92% and 0. 85% (n=9), respectively. Conclusion:The method is special, stable and reliable, and can be used for the content determination of compound atorvastatin calcium and amlodipine besylate tablets.