以液相層析法多重分析製藥中 Atorvastatin Calcium 及 Ezetimibe   全文下載

Simultaneous Determination of Atorvastatin Calcium and Ezetimibe in Pharmaceutical Formulations by Liquid Chromatography

一種簡單、具精確性及靈敏度的逆相高效液相層析法已被開發，其應用於製藥中atorvastatin calcium及ezetimibe之定量。利用HypersilR phenyl-2管柱（250 × 4.6 mm，5 μ）進行層析分離。波長242 nm下，移動相為0.1 m醋酸銨（pH 6.5）/乙?（28:72，v/v）。atorvastatin calcium及ezetimibe之濃度範圍為12-52 μg ml-1時，校正曲線為線性，相關係數（r2）介於0.9966-0.9993。儀器分析總時程少於5 min。此法藉由測試其線性、回收率、選擇性、再現性及最低檢測濃度/最低定量極限而行方法確效，結果證實本方法可成功地應用在製藥中atorvastatin calcium及ezetimibe之檢測。

A simple, precise and sensitive reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitation of atorvastatin calcium simultaneously with ezetimibe in pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ Hypersil® phenyl-2 column. Eluent was monitored by absorbance at 242 nm using a mixture of 0.1 M ammonium acetate (pH 6.5) and acetonitrile in the ratio of 28:72 (v/v). Calibration plots were linear in the concentration range of 12-52 μg mL-1 for both atorvastatin calcium and ezetimibe with correlation coefficient (R2) between 0.9966 and 0.9993. The total run time is less than 5 min. The proposed method was validated by testing its linearity, recovery, selectivity, repeatability and LOD/LOQ values and it was successfully employed for the determination of atorvastatin calcium and ezetimibe in pharmaceutical tablet formulations.