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Method Development and Validation of Ramipril and Amlodipine Besylate by RP-HPLC


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1 Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India
     

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A simple isocratic RP-HPLC method has been developed and subsequently validated for the determination of Ramipril and Amlodipine Besylate in pharmaceutical dosage forms within very short retention time. The method employs an Xterra C18 column, 5 μ, 150 mm x 4.60 mm id with flow rate of 1.5 ml/min using UV detection at 210nm. The separation was carried out using a mobile phase consisting of Sodium Lauryl Sulfate buffer by adjusting pH 2.5 and final composition is Buffer: Acetonitrile: Methanol (45:16.5:38.5)V/V. The retention time for Ramipril and Amlodipine Besylate was found to be 3.1 minutes and 3.8 minutes respectively. The results of analysis were validated statically and by recovery studies. Hence the proposed method was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

Keywords

RP-HPLC, Sodium Lauryl Sulfate Buffer, Ramipril, Amlodipine Besylate.
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  • Method Development and Validation of Ramipril and Amlodipine Besylate by RP-HPLC

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Authors

N. I. Kochar
Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India
M. N. Dahake
Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India
R. L. Bakal
Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India
A. P. Devani
Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India
A. V. Chandewar
Department of Quality Assurance, P.W. College of Pharmacy, Dhamangaon Road, Yavatmal, 445001, India

Abstract


A simple isocratic RP-HPLC method has been developed and subsequently validated for the determination of Ramipril and Amlodipine Besylate in pharmaceutical dosage forms within very short retention time. The method employs an Xterra C18 column, 5 μ, 150 mm x 4.60 mm id with flow rate of 1.5 ml/min using UV detection at 210nm. The separation was carried out using a mobile phase consisting of Sodium Lauryl Sulfate buffer by adjusting pH 2.5 and final composition is Buffer: Acetonitrile: Methanol (45:16.5:38.5)V/V. The retention time for Ramipril and Amlodipine Besylate was found to be 3.1 minutes and 3.8 minutes respectively. The results of analysis were validated statically and by recovery studies. Hence the proposed method was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

Keywords


RP-HPLC, Sodium Lauryl Sulfate Buffer, Ramipril, Amlodipine Besylate.