Simultaneous Determination of Atorvastatin Calcium and Ezetimibe in Pharmaceutical Formulations by Liquid Chromatography
SYED SHANAZ QUTAB1, SYED NAEEM RAZZAQ1, ISLAM ULLAH KHAN2*, MUHAMMAD ASHFAQ2 AND ZEBA AHMAD SHUJA1
1. Schazoo Laboratories (Pvt) Ltd., 45 G.T. Rd., Lahore-54000, Pakistan
2. Department of Chemistry, Government College University, Lahore-54000, Pakistan
(Received: October 16, 2006; Accepted: February 2, 2007)
Abstract
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.
Key words: HPLC, acetonitrile, isocratic, atorvastatin calcium, ezetimibe