RP-HPLC Method Development and Validation for Simultaneous Estimation of Telmisartan and Ramipril in pure and Pharmaceutical Dosage forms

摘要

A new, precise, accurate, rapid and simple reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of Telmisartan (TEL) and Ramipril (RAM) in pharmaceutical formulation and in bulk. The drugs were estimated using Shiseido C_(18) (250 x 4.6 mm, 5μm) column. The mobile phase is 0.5% orthophosphoricacid (A), combination of acetonitrile: methanol (70:30, v/v) (B). A: B in the ratio of (50:50, v/v) at a flow rate of 1 ml/min was used for the separation. Detection was carried out at 210 nm .Linearity was obtained in the concentration range of 40-120 μg/ml for TEL, 5-15μg/ml for RAM with retention times of 3.218 minutes and 4.803 minutes respectively. The correlation coefficient values were found to be greater than 0.99. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of TEL and RAM are in the range of 99.91-99.97% and 99.76-99.86% respectively. The assay results of TEL and RAM are 99.91% and 99.82% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.01 μg /ml, 0.8 μg /ml for TEL and 0.1μg /ml, 3μg /ml for RAM respectively. The method was validated as per ICH guidelines. The proposed validated method can be successfully used for the quantitative analysis of Telmisartan (TEL) and Ramipril (RAM) in bulk and commercially available dosage form.