DEVELOPMENT AND VALIDATION OF SPECTROFLUORIMETRIC METHOD FOR THE ESTIMATION OF VOGLIBOSE IN BULK AND PHARMACEUTICAL DOSAGE FORMAbstract
A simple, accurate, sensitive, reproducible and cost – effective spectrofluorimetric method was developed for the estimation of voglibose in bulk and pharmaceutical formulations. The solvent systems, wavelengths of detection (excitation and emission) were optimized in order to maximize the sensitivity and minimize the cost of analysis for voglibose. Derivatization procedure was employed for analysis. Voglibose showed strong native fluorescence in Methanol having excitation at 282 nm and emission at 345 nm. Effect of different solvents was thoroughly investigated. All parameters like the effect of different solvents, pH, dilutions, reaction time, temperature and effect of excipients were thoroughly investigated. The linear regression equations obtained by least square regression method for Fluorescence Intensity (FI) and concentration in ng/ml. The calibration curve was linear in the range from 100 to 350 ng/ml .The developed method was successfully employed with high degree of precision and accuracy for the estimation of total drug content in commercial tablet formulation of Voglibose (volix).The results of analysis were treated statistically, as per International Conference On Harmonization (ICH) guidelines for validation of analytical procedures, stability studies and by recovery studies. The percentage recovery was found to be in between 98.0 % to 98.5 %. The results were found to be in good agreement with the label claims.
Mallikarjuna Rao N.*, Bagyalakshmi J. and Ravi T. K.
College of Pharmacy, Sri Ramakrishna Institute of Paramedical Science, New Siddapudur, Coimbatore, India
20 March, 2010
10 May, 2010
15 May, 2010
01 June, 2010