Developed and validated for simultaneous estimation of telmisartan, and cilnidipine, metoprolol in tablet form, a method using reversed-phase high-performance liquid chromatography (RP-HPLC)

Abstract

A reversed-phase high-performance liquid chromatography (RP-HPLC) method was established to separate and quantify Metoprolol succinate, Telmisartan, and Cilnidipine. The separation was achieved using a Shimadu Shimpack Solar 5 μm C18 Dimension 4.6x250 mm as the stationary phase. The mobile phase consisted of a phosphate buffer with a pH of 3.0 and acetonitrile, and gradient elution was employed. The flow rate was set at 1.0 ml/min. The detection was performed at a wavelength of 245 nm. The medications are separated and released at specific periods during the chromatographic process. Telmisartan is eluted at a retention time of 14.2 minutes, Metoprolol succinate at 6.3 minutes, and Cilnidipine at 22.2 minutes. The approach exhibits linear behaviour within the concentration ranges of 10-50 μg/ml, 50-250 μg/ml, and 3-15 μg/ml for Telmisartan, Metoprolol succinate, and Cilnidipine, respectively. The regression coefficients for these compounds are 0.997, 0.995, and 0.999, respectively. The approach is highly accurate within the permitted limits, with a relative standard deviation of 1.22%.The suggested approach demonstrated linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), limit of quantification (LOQ), and system appropriateness results that met the acceptance requirements set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This approach is suitable for the regular analysis of pharmaceutical formulations.