RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination

Abstract

Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients.  Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture.  Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min.  Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte.  Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.  

A Review on Simultaneous Determination of Anti-Hypertensive Drug Combinations Containing Amlodipine Besylate using Chromatographic Analysis

“…The linearity (correlation coefficient >0.999) obtained from the calibration curve for concentration ranges was 40-200 μg/ml for Telmisartan, 10-50 μg/ml for Rosuvastatin calcium, and 5-25 μg/ml for Amlodipine besylate. Assay from the chromatogram for bulk mixture of combination was 99.24%, 100.21% and 99.98% respectively for Amlodipine besylate, Rosuvastatin calcium and Telmisartan [49] .…”