Authors : T. B. Deshmukh, S. S. Deo and F. Inam
Page Nos : 355-361
Description :
ABSTRACT
A simple, economical, specific, accurate, precise and validated Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for Tacrolimus in pharmaceutical dosage form. The chromatographic separation was achieved on Princeton SPHER C8 column (150 mm x 4.6 mm id, 5 μ particle size) at 500c temperature using mobile phase buffer (0.05 M Potassium dihydrogen phosphate) : Acetonitrile (ACN) : tert-butyl methyl ether (35:60:5% v/v/v) (pH 3.0 ± 0.05) at flow rate 1.0 ml/min. Quantification was achieved with UV detector at 210 nm. Retention time of Tacrolimus was found to be 6.02 ± 0.05 min. Linearity was studied in the concentration range 20-120 μg/ml for Tacrolimus with a correlation coefficient of 0.9986. The proposed method was validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness, LOD, and LOQ. The developed method with good separation, successfully applied for determination of Tacrolimus in its pharmaceutical dosage form.
Keywords: RP-HPLC, Tacrolimus, Validation.
