Abstract
Pre-formulation studies are an integral part of formulation development. For the successful development of the formulation, it is essential to perform all the pre-formulation studies. The present work was aimed at systematically investigating the physicochemical properties of aceclofenac, a non-steroidal anti- infl ammatory drug used for the management of rheumatoid arthritis, osteo arthritis and ankylosing spondylitis. The studies included pre-formulation profi ling of the drug in order to fi nalize the excipients for the development of its delivery. Drug characterization was carried out for solubility in different solvent systems, pKa determination, bulk characterization, melting point, dissolution. Further, and some other parameters RP-HPLC method for estimation of the drug was developed and validated. Earlier methods were developed using C18 column for the estimation of drug content. In the present research, an attempt was made to develop and validate an analytical method using HILIC column. The pre-formulation profi ling of the drug was successfully done and a sensitive analytical method was also developed.
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