The development of appropriate invitro Dissolution method for drug products with practically insoluble or limited water solubility has been challenging to the pharmaceutical industry. Ezetimibe is the first lipid-lowering drug that inhibits intestinal up take of dietary and biliary cholesterol without affecting the absorption of fat soluble nutrient. Ezetimibe is BCS class-II drug. It is highly soluble in alcohol (ethanol), methanol and acetone, but practically insoluble in water. The objective of present study is to enhance the solubility of Ezetimibe in water by using surfactants like sodium lauryl sulfate, Polysorbate-80, Polysorbate-20. By using specified surfactant the dissolution rate is enhanced. To Quantify the dissolution rate an analytical method was developed by using High performance liquid chromatography method.The chromatographic method comprising column C18 (100x4.6mmx3.5μm),flow rate 1.0 ml/min and detection wavelength 232nm. This method was validated for parameters such as specificity precision, accuracy, linearity, robustness solution stability as per international Conference on Harmonization(ICH) guidelines. This method is successfully applied to formulated tablets containing Ezetimibe.
June 9, 2016
The right to download or print any of the pages of this thesis (Material) is granted by the copyright owner only for personal or classroom use. The author retains all proprietary rights, including copyright ownership. Any reproduction or editing or other use of this Material by any means requires the express written permission of the copyright owner. Except as provided above, or any use beyond what is allowed by fair use (Title 17 Section 107 U.S.C.), you may not reproduce, republish, post, transmit or distribute any Material from this web site in any physical or digital form without the permission of the copyright owner of the Material. Inquiries regarding any further use of these materials should be addressed to Administration, Jernigan Library, Texas A&M University-Kingsville, 700 University Blvd. Kingsville, Texas 78363-8202, (361)593-3416.