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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2011)

Validated HPTLC Method for Determination of Amlodipine Besylate and Perindopril Erbumine in Bulk Drug and in Pharmaceutical Dosage Form

T. C. Borole1, S.P. Gandhi, A.V. Ladke and M. C. Damle*

Abstract
A simple high-performance thin-layer chromatographic (HPTLC) method for separation and quantitative analysis of Amlodipine Besylate and Perindopril Erbumine in bulk and in pharmaceutical formulations has been established and validated. After dissolving in methanol, sample and standard solutions were applied to prewashed silica gel plates and developed with Dichloromethane: Methanol: Glacial acetic acid: (8.5:1.5:0.1ml v/v/v) as mobile phase. Zones were scanned densitometrically at 238 nm. The Rf values for Amlodipine Besylate and Perindopril Erbumine were 0.200.02 and 0.890.02 respectively. Calibration plots were linear in the ranges 500–2500 ng/band for Amlodipine Besylate and 6000–18000 ng/band for Perindopril Erbumine; the correlation coefficients (r2) were 0.995 and 0.995 respectively. LOD and LOQ for Amlodipine Besylate were 10.31 and 32.10ng/band. For Perindopril Erbumine they were 179 and 544ng/band, respectively. The suitability of this method for quantitative determination of these compounds was proved by validation in accordance with the requirements of pharmaceutical regulatory standards. The method was used for routine analysis of these drugs in bulk and in a formulation.
Introduction
Amlodipine Besylate chemically, 3-Ethyl 5-methyl (4RS) 2-[(2-aminoethoxy)methyl]-4 (2-Chlorophenyl)-6-methyl 1,4-dihydropyridine-3,5-dicarboxylatebenzenesulphonate(1). Amlodipine belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases(3). Perindopril Erbumine chemically, 2-Methylpropan-2-amine (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl) butyl]amino]propanoyl octahydro-1H-indole-2-carboxylate(2). Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease. Perindopril is a prodrug of perindoprilat, which is a competitive ACE inhibitor. It acts as a vasodilator and it reduces peripheral resistance(3). Literature survey reveals that a variety of spectrophotometric(4-7) and chromatographic methods[8-17] have been reported for determination of Amlodipine besylate. Variety of spectrophotometric(20,21) and chromatographic methods[18,19,22,23,24] have been reported for Perindopril Erbumine in pharmaceutical dosage forms either alone or in combination with other drugs. To the best of our knowledge, no TLC method has been reported for simultaneous estimation of Amlodipine besylate and Perindopril Erbumine in the combined dosage form. The objective of this investigation was, therefore, to establish an HPTLC Method for simultaneous estimation of Amlodipine Besylate and Perindopril Erbumine in bulk and in tablet dosage form. The developed method was validated as per the ICH guidelines for validation of analytical procedures.This validated method may be used for routine analysis of this combination(25).

 

 

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