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 60F254 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.
Highlights
Amlodipine besylate (AB) is 3-ethyl 5-methyl 4RS-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5dicarboxylate benzene sulphonate [1], (Figure 1)
The literature survey revealed that there are some analytical methods for the determination of Perindopril Erbumine including Potentiometric [1], HPLC [5], LC-MS [6] and CE [7]
Amlodipine besylate was determined by spectrophotometric [8,9,10], Spectrofluorometric [11], LC [1], RP-HPLC [12,13,14], LC-MS [15], HPTLC [16] and HPLC stability indicating assay method [17]
Summary
Amlodipine besylate (AB) is 3-ethyl 5-methyl 4RS-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5dicarboxylate benzene sulphonate [1], (Figure 1). It is a calcium channel blocker [2], used as an anti-hypertensive and in the treatment of angina, it lowers the blood pressure, relaxes heart muscles and dilates the heart blood vessels to prevent spasm [3]. Perindopril L-arginine (PA) is (2S, 3aS, 7aS)-1-N-[(S)-1-ethoxycarbonyl butyl]-L-alanyl) perhydroindole-2– carboxylate [4] (Figure 2) It is an angiotensin converting enzyme (ACE) inhibitor used for the treatment of hypertension. The developed RP-HPLC method has an additional advantage that can be applied for determination of the proposed drugs in plasma in therapeutic drug monitoring studies because of its high sensitivity and suitable Rf values of the separated peaks to their in vitro analysis
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