Analytical Method Development and Validation by RP-HPLC Method in Bulk and Tablet Dosage form of Tacrolimus and Guggulsterone

Ramesh Dhani*, M. Gobinath, Sonalika Patro, T. Lavanya, A. Rajesh, G. Divya, C. Yamini, R. Pravallika
Ratnam Institute of Pharmacy, Pidathapolur, SPSR Nellore, Andhra Pradesh, India.

A B S T R A C T
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of tacrolimus and guggulsterone was done by RP-HPLC. Present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible RP-HPLC method for the simultaneous analysis of Tacrolimus and guggulsterone. The Phosphate buffer was p^H 3.0 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of 70:30 % v/ v. symmetry C₁₈ column   C18 (4.6 x 150mm, 5mm) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 256 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of tacrolimus and guggulsterone were found to be from 10-50 mg/ml of tacrolimus and 60-300 mg/ml of guggulsterone. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of tacrolimus and guggulsterone .LOD and LOQ were found to be within limit.
Keywords: Tacrolimus and guggulsteron, RP-HPLC, symmetry C18 column.