In the present study we report the development and validation of reversed-phase high performance liquid chromatographic method for the determination of the tacrolimus in presence of pharmaceutical excipients. The developed method was validated with the guidelines of ICH parameters. Also, the forced degradation studies were performed to develop a stability-indicating high performance liquid chromatographic (HPLC) method for tacrolimus-in the presence of the degradation products. The mobile phase was acetonitrileâwater 85:15 (v/v). The calibration plot for the drug was linear in the range 25 â 250 ?g/mL was developed on JASCO fully automated HPLC system with Photo-diode array detector at 210 nm wavelength. The method was accurate and precise with limits of detection and quantitation of 4.86 and 14.73 ?g, respectively. Mean recovery was 101.05%. In conclusion we report here an simple, precise and accurate developed RP- HPLC method having validated ICH parameters which can scale up to commercial level for the simultaneous quantification of Tacrolimus in dosage form as well as bulk drugs for quality control purpose.
