A Novel Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form

Abstract

A novel stability indicating reverse phase liquid chromatographic method has been
developed for the simultaneous estimation of Losartan Potassium, Ramipril and
Hydrochlorothiazide in bulk and Pharmaceutical formulations by using reverse phase
Kromasil 100-5 C18 column [250mm x 4.6mm].The mobile phase (Methanol: phosphate
buffer-pH 4.0) in the ratio of 70:30% v/v was pumped at a flow rate of 0.8ml/min and
the column effluents were monitored at 233nm using Variable Wavelength UV detector.
Linearity was obtained in the concentration range of 100-500 µg/ml for Losartan
Potassium, 10-50 µg/ml for Ramipril and 20-100µg/ml for Hydrochlorothiazide. The
established method was statistically validated according to the ICH Q2B guidelines and
the percentage relative standard deviation for precision, robustness and ruggedness was
found to be less than 2% indicating high degree of precision and robustness. The
percentage recovery for the accuracy was found to be 100.76%, 96% and 98% for
Losartan Potassium, Ramipril, and Hydrochlorothiazide respectively which were within
the specified limits of recovery. Assay for the marketed formulation proved that
100.76% of Losartan Potassium and 96% of Ramipril and 98.22% of
Hydrochlorothiazide. The proposed analytical method was observed for various stress
condition and it was proved that more stable even under acidic, alkaline, peroxide and thermal degradation conditions. Hence due to its simplicity, rapidity, precision, accuracy
and stability the developed HPLC method can be applied for the estimation of Losartan
Potassium, Ramipril and Hydrochlorothiazide in pure and marketed formulations by a
modern analyst