Thursday , 29 February 2024

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.

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 pH 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.

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