Bioanalytical Method Development and Validation of Eprosartan Mesylate and Hydrochlorthiazide using RP-HPLC in Human plasma

Abstract

A precise, very rapid and cheaper RP-HPLC method that is reproducible and stable is developed aiming for estimating Eprosartan mesylate and hydrochlorothiazide simultaneously in an active pharmaceutical ingredient and tablet dosage form. This method relies on the simplicity and easy to run fashion. The diluent/solvent was selected based on the solubility of the drugs. The RP-HPLC analysis was performed using an Agilent system C18 (150mm x 4.6mm, 5m) column with a mobile phase of 0.1% orthophosphoric acid pH (2.2): Acetonitrile (60:40), Flow rate 1.0ml/min, Detector wavelength 240nm. Calibration was linear for Eprosartan (80-3200ng/ml) and Hydrochlorothiazide (8.5-340ng/ml). The value of r2 was more than 0.999 consistently. The accuracy within the same day and during the course of estimation of plasma samples were investigated, and it was discovered that the mean percent accuracy was very highwith ranges from 100.13 to 100.66% intra-day and 99.16 to 100.87% inter-day. On the basis of the analytes and plasma samples, the precision (percent CV) was computed and found to be 0.91-1.76% for intraday and 0.98-1.58% for inter-day. Eprosartan and Hydrochlorothiazide had 98.85% and 98.67% mean recovery.The percent mean stability of Eprosartan was determined to be 99.90% at 28°C and 100.16% at 80°C. The percent mean stability of Hydrochlorothiazide was determined to be 100.94 at 28°C and 101.11 at 80°C. The newly discovered approach has been effectively used to the regular examination of pharmaceutical formulations for pharmaceutical drugs.