STABILITY-INDICATING RP-HPLC CHROMATOGRAPHIC METHOD TO STUDY THE DEGRADATION BEHAVIOUR OF TACROLIMUS

Mehta Hiralben Satishchandra*, Dr. Indrajeet Singhvi and Dr. Hasumati Raj

ABSTRACT

Tacrolimus (TAC) is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-dihydroxy-12-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl] prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-(prop-2-en-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.0,]octacos-18-ene-2,3,10,16-tetrone. (TAC), its available as a topical decongestant in formulations, it is also used to atopic dermatitis. In this study, degradation behavior of Tacrolimus was studied by subjecting the drug to various ICH stress conditions. Also a new, simple, sensitive and accurate stability-indicating method was established for quantitative determination of Tacrolimus in the presence of various and related compounds (Impurity I and II). An expectable separation was achieved with ODS C18 column with flow rate 1.0 ml/min. UV Detection wavelength was used for estimation of Tacrolimus over a concentration range of 10 – 300 μg/ml with mean recovery of 99.87 – 100.12%. Methods can analysis Tacrolimus related compound LOQ limit up to 0.031 μg/ml. Method can well resolve all degraded product as compare to Tacrolimus. Developed method can routinely use for the estimation of Tacrolimusrelated compounds from the dosage form and also for stability sample.

Keywords: Related Compounds, Stability Indicating, HPLC.