Development and validation of stability-indicating ultra high-performance liquid chromatography for ramipril analysis in pharmaceutical dosage forms and its application in lipid-based formulations

Abstract

The current study evaluates the Ultra High performance Liquid Chromatography (UHPLC) method for the quantification of Ramipril in lipid-based formulations. A reliable, highly precise, more specific and reproducible reversed phase UHPLC method has been developed and validated according to the regulatory guidelines, which was composed of isocratic mobile phase; acetonitrile and 0.25% formic acid solution in ratio of (40:60 %V/V) with a flow rate of 0.2 mL/min, and C18 column (2.1×50 mm, 1.7 μm). The detection was carried out at 210 nm. The developed UHPLC method was found to be rapid (3 min. run time), selective with high resolution of Ramipril peak (1.4 min.) from different lipid matrices and highly sensitive (Limit of Detection and Lower Limit of Quantification were 0.034 μg/mL and 0.199 μg/mL, respectively). The linearity, accuracy and precision were determined as acceptable over the concentration range of 1 - 200 μg/mL for Ramipril. The results showed that the proposed UHPLC method can be used for the estimation of Ramipril in lipid-based formulation by indicating its purity and stability with no interference of excipients or related substances of active pharmaceutical ingredient.