Volume : VII, Issue : VII, July - 2017

VALIDATION OF SOP OF DISSOLUTION APPARATUS USING ACELOFENAC TABLETS

Miss Preeti Yadav, Mr. Rehan Uddin

Abstract :

 A dissolution method was validated for evaluation of the dissolution behavior of tablet dosage form containing aceclofenac as there was no official method available. Four different commercially available products were selected for this study.The method was validated according to International Conference on Harmonisation (ICH) guidelines

which include accuracy, precision, specificity, linearity, and analytical range. In addition, stability and solubility of  the drug in different media i.e., water, 0.1 N HCl, acetate buffer and phosphate buffer of different pH were studied. Based on this, dissolution medium containing 0.02 M phosphate buffer, pH 6.8, was found suitable to ensure sink conditions and chemical stability for both the drugs. The established dissolution conditions were 900 ml dissolution medium at temperature 37 ± 0.5°C, using USP apparatus II at stirring rate of 50 rpm for 40 min. The corresponding dissolution profiles were constructed and all the selected ands showed more than 80% drug release within 30 min. The in vitro release profiles were compared for the similarity using the f2 test. Thus, the proposed dissolution method can be applied successfully for the quality control of aceclofenac tablets.

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Article: Download PDF   DOI : 10.36106/ijar  

Cite This Article:

Miss Preeti Yadav, Mr. Rehan Uddin, VALIDATION OF SOP OF DISSOLUTION APPARATUS USING ACELOFENAC TABLETS, INDIAN JOURNAL OF APPLIED RESEARCH : Volume‾7 | Issue‾7 | July‾2017

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