RP-HPLC method development and validation for simultaneous estimation of ramipril and felodipine

Abstract

A rapid and sensitive High Performance Liquid Chromatography (HPLC) method has been developed and validated as per ICH guideline for simultaneous determination of ramipril and felodipine binary mixture. Chromatographic separation was achieved on a Hyperchom C18 column (250 × 4.6 mm i.d., 5 μm) using an isocratic mobile phase of potassium di-hydrogen phosphate (pH = 3.4): methanol: acetonitrile in the ratio 15:15:70 (v:v:v). The flow rate was 1.5 mL/min, temperature of the column was maintained at 30 °C and detection was made at 210 nm. Linearity studies indicated that the drugs obey Beer’s law over the range of 10-80 μg/mL for ramipril and 5-80 μg/mL for felodipine. The proposed method is precise, accurate, linear and robust. The short retention time allows the analysis of a large number of samples in a short period of time and, therefore, considered to be cost-effective that can be used for routine analysis of both drugs in the pharmaceutical industry.