Acta Pharm. 66 (2016) 479-490
Original research paper
Development and validation of HPLC and CE
methods for simultaneous determination of amlodipine and atorvastatin in the
presence of their acidic degradation products in tablets
SAID A.
HASSAN, EMAN S. ELZANFALY, MAISSA Y. SALEM and BADR A. EL-ZEANY
Faculty of Pharmacy, Department of Analytical Chemistry,
11562, Cairo, Egypt
Accepted May 1, 2016
Published online September
6, 2016
Two methods were developed for separation and quantitation of amlodipine
(AML) and atorvastatin (ATV) in the presence of their acidic degradation
products. The first method was a simple isocratic RP-HPLC method while the
second was capillary electrophoresis (CE). Degradation products were obtained
by acidic hydrolysis of the two drugs and their structures were elucidated for
the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the
assays were therefore stability-indicating. The linearity of the proposed
methods was established over the ranges 1–50 μg mL–1 for
AML and ATV in the HPLC method and in the range of 3–50 and 4–50 μg mL-1 for AML and ATV, respectively, in the CE method. The proposed
methods were validated according to ICH guidelines. The methods were
successfully applied to estimation of AML and ATV in bulk powder and in
pharmaceutical dosage forms.
Keywords: atorvastatin, amlodipine, capillary zone electrophoresis, HPLC, stability, acidic