Separation and characterization of the hydrolytic degradation products of amlodipine and atorvastatin and development of RP-HPLC method for quantitative determination in bulk powder and dosage form
S A Hassan, E S Elzanfaly, M Y Salem and B A El-Zeany
Cairo University, Egypt
: J Diagnos Tech Biomed Anal
Abstract
Amlodipine (AML) and atorvastatin (ATV) were subjected to acidic hydrolysis and their degradation products were separated and their structures were confirmed. A simple stability indicating isocratic reversed phase high performance liquid chromatographic method was developed and validated for the simultaneous determination of AML and ATV in presence of their hydrolytic degradation products. The proposed RP-HPLC method utilizes Agilent Zorbax® ODS 5 um, 4.6 x 250 mm column, at ambient temperature, mobile phase consisting of acetonitrile:methanol:phosphate buffer solution (45: 30: 25 by volume), pH adjusted to 2.5±0.1 with orthophosphoric acid, at a flow rate of 1.0 mL/min and UV detection at 254 nm. The proposed method was valid in the range of 0.8–30 µg/mL (r=0.9999) for AML and 0.4-30 µg/mL (r=1.0000) for ATV. The degradation products did not interfere with the determination of both drugs and the assay can thus be considered stability-indicating. The proposed method was validated according to ICH guidelines and successfully applied to the estimation of AML and ATV in bulk powder and pharmaceutical dosage forms.
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