Validated Chromatographic Methods for Simultaneous Determination of Amlodipine Besylate and Perindopril Arginine in Binary Mixtures and in Pharmaceutical Dosage Form

Abstract

Two accurate, selective and precise chromatographic methods, namely TLC-densitometric method & RP-HPLC method & were developed and validated for the simultaneous determination of Amlodipine besylate and Perindopril Arginine in their binary mixtures.The developed TLC-densitometric method depends on separation and quantitation of the studied drugs on silica gel 60F 254 TLC plates. Chloroform:methanol:deionized water:glacial acetic acid:triethylamine (10:7:5:0.3:0.2, by volume) was used as developing system and the separated bands were scanned at 208 nm. Linear relationship was obtained in the range 1-10 µg for both drugs.The developed RP-HPLC depends on quantitative chromatographic separation of the studied drugs on a C18 column using phosphate Buffer:acetonitrile (60:40, v/v), pH=4.6 as a mobile phase delivered at constant flow rate of 1 mL.min -1 with UV detection at 210 nm. Calibration curves for Amlodipine besylate and Perindopril Arginine were constructed over the concentration range of 1-50 µg.mL -1 for both drugs.The proposed methods were successfully applied for determination of the studied drugs in their bulk powder and in pharmaceutical formulations. The proposed methods were statistically compared to each other using student's t test and F-test and no significant difference was found between them.