ABSTRACT

Ramipril is an Angiotensin Converting Enzyme (ACE) inhibitor, an anti-hypertensive drug. The aim of the present work was to develop simple, precise, accurate, specific, stabilityindicating RP-HPLC method for the assay determination of Ramipril in bulk and pharmaceutical dosage form. The separation is achieved using Agilent TC-C18 (2), 5µm, 4.6×250mm column in isocratic mode with mobile phase, Acetonitrile:Methanol:Phosphate buffer (60:20:20v/v/v) at a flow rate of 1.0ml/min. Detection is carried out at 215nm. The retention time for ramipril is 1.635 minutes. The RP-HPLC is validated with respect to specificity, accuracy, precision, linearity range, limit of detection (LOD), limit of quantification (LOQ), system stability studies, robustness, ruggedness with intraday and interday variation studies. The percent recoveries ranged between 95-105 % and RSD < 2%. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. Linearity was observed in the concentration range of 10 to 100% with correlation coefficient >0.995. The percent of relative standard deviation of six replicate measurements was found to be 1.76 which indicates that the proposed method was precise. The method could be successfully used for the analysis of Ramipril in bulk and pharmaceutical dosage form. Keywords: Ramipril, ACE inhibitor, RP-HPLC
Publication date: 01/11/2021

https://ijbpas.com/pdf/2021/November/MS_IJBPAS_2021_5730.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.11.5730