Determination of active ingredients in antihypertensive drugs using a novel green HPLC method approach.

Abstract

A novel, sensitive, fast, and pratic RP-HPLC methods were presented for the quantitative amounts of Telmisartan (TEL) and Olmesartan (OLM) in the presence of Amlodipin (AML) in a binary mixture of pharmaceutical preparation. Waters Spherisorb ODS-2 C18 column was used for separation. These methods were valid over linearity ranges of 2.5-30μμg/mlL, 2-85μμg/mlL, and 2-35μμg/mlL for OLM, TEL, and AML, respectively. The mobile phase system consisted of acetonitrile:methanol: phosphate buffer at pH 3.0 (65:5:30 v/v/v), and the flow rate was 1,5mlL/min for OLM and AML. The mobile system's other mixture (TEL and AML) was acetonitrile:methanol: phosphate buffer at pH 2.5 (65:5:30 v/v/v), and the flow rate was 1,5mlL/min. These procedures were successfully applied to bulk, laboratory synthetic mixture, and medicinal dosage forms to use active ingredients quantitatively. The studied methods were validated according to ICH guidelines. In the developed HPLC method, the limit of detection values was found to be 0.020μμg/mlL for TEL, 0.025μμg/mlL for OML, and 0.070μμg/mlL for AML. The correlation coefficients for the HPLC method were found to be 0.9938 for TEL, 0.9996 for OML, and 0.9982 for AML. The calibration range is between 2.5 and -30, 5-35, and 2-85μμg/mlL for OLM, AML, and TEL, respectively. The proposed HPLC method is a convenient, effective, sensitive, green, and time-saving method for the rapid determination of TEL and OLM in the presence of AML.