Affiliation:
1. Government Pharmacy College, Gandhinagar, India.
2. Department of Quality Assurance, B. K. Mody Government Pharmacy College, Rajkot, India.
3. L. M College of Pharmacy, Ahmedabad, India.
Abstract
The present study describes the development and validation of multimedia dissolution method by UV- Visible Spectroscopy to evaluate the dissolution behavior of deflazacort tablets. The different dissolution media selected for this study are water, 0.1N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. Spectra of deflazacort in different dissolution media were recorded in range of 200-400nm and 247nm selected as maximum absorptive point. Stability and solubility of deflazacort in different dissolution media i.e., water,0.1 N HCL, pH 4.5 acetate buffer, pH 6.8 phosphate buffer were also studied. Based on this, dissolution medium containing 0.1 N HCL, water and pH 4.5 acetate buffer were found suitable to ensure chemical stability of the deflazacort. The established dissolution conditions were 1000ml dissolution medium, apparatus USP II (paddle), agitation speed 50 RPM for 75 minutes and it is corresponding to>90 % drug release within 60min. The method was validated according to ICH guideline that include accuracy, precision, specificity/selectivity and linearity. Hence, it could be concluded that the developed method can be used as dissolution method for estimation of release of deflazacort in tablet dosage form.