DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR DETERMINATION OF DORIPENEM IN HUMAN PLASMA AND PHARMACEUTICAL DOSAGE FORMS

Abstract

Doripenem is drug that belongs to the class of carbapenems, and it is commonly used to treat the infections caused by bacteria. The main theme behind this study plan was to develop and validate a simple, economically suitable, sensitive, less time-consuming, and rapid HPLC method for the determination of doripenem in human plasma and pharmaceuticals. For UV spectroscopy, water was used as a solvent, and analysis was carried out at several wavelengths. Doripenem showed maximum absorbance at 298nm. In the HPLC method, a mixture of acetonitrile and water(40:60%v/v) was used at 1 mL/min for the determination of the drug. The stationary column used was Thermo Scientific ODS Hypersil C₁₈ (250 × 4.6 mm, 5 µm) at room temperature and this method was developed using ICH guidelines. The proposed method showed accuracy, linearity, sensitivity, and it was also specific for stress degradation studies i.e., acidic (0.1 N HCl), basic (0.1 N NaOH), oxidative (3% H₂O₂), photolytic (200-800 nm, 3h) and thermal (70 °C, 2 h). The proposed method was successfully developed and validated for the determination of doripenem.