RP-HPLC method development and validation for the simultaneous estimation of ramipril and losartan in tablet and pharmaceutical dosage form

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated
for simultaneous determination of Ramipril and Losartan in pharmaceutical tablet dosage form. Chromatographic analysis
was performed on a Inertsil ODS (250×4.6× 5µ)column at ambient temperature with a mixture of 10mM KH2PO4:ACN
(30:70) v/v (1.36gm of potassium di hydrogen phosphate (KH2PO4) was weighed and dissolved in 1000ml of water and
volume was made up to 1000ml with water. Adjust the pH to 3.0 using ortho phosphoric acid. The buffer was filtered
through 0.45µ filters to remove all fine particles and gases) as mobile phase, at a flow rate of 1.0 ml/min-1
. UV detection
was performed at 211 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The
retention times of Ramipril and Losartan were 2.667 and 3.887 min, respectively. Calibration plots were linear over the
concentration ranges 3-7 μg mL-1
and 60-140 μg mL-1
for Ramipril and Losartan, respectively. The Limit of detection was
0.24 and 1.09 µg mL-1
and the quantification limit was 0.72 µg mL-1
and 3.30 µg mL-1 for Ramipril and Losartan,
respectively. The accuracy of the proposed method was determined by recovery studies and found to be 100.12% to
100.43%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method
is applicable to routine analysis of determination of Ramipril and Losartan in pharmaceutical tablet dosage form.