AbstractsAstronomy & Space Science

Analytical method development and method validation for assay related compound and degradants of temozolomide and anastrozole as anti cancer drug products;

by Daphal Vinayak Nathu

Institution: Shri Jagdishprasad Jhabarmal Tibarewala University
Year: 2014
Keywords: Chemistry
Record ID: 1184482
Full text PDF: http://shodhganga.inflibnet.ac.in/handle/10603/15217


Quality is important in every product or service, but it is vital in medicine as it involves life. Unlike other consumer goods, there can be and there is no second quality. Therefore analytical methods which are a measure of quality of the drugs play a very newlinecomprehensive role in drug development and follow up activities, to assure that a drug newlineproduct meets the established standard, are a stable and will continue to meet purported newlinequality throughout its shelf life newlineThese methods should be selective and sensitive to monitor the known and unknown newlineimpurities, have to be written in a format such that they can be produced over a period of time and from laboratory to laboratory, i.e. these methods should be validated. newlineAnalytical methods should be used within good manufacturing practice (GMP) and good newlinelaboratory practice (GLP) environments, and must be developed using the protocols set newlineout in the International Conference on Harmonization (ICH) guidelines (Q2A and Q2B) newlineThe US Food and Drug Administration (FDA) and US Pharmacopoeia (USP) both refer newlineto ICH guidelines, i.e. these methods should be validated. The specific aim was to develop a method, which can be used simultaneously for the estimation of Anastrozole and Temozolomide and also for the estimation of their related compounds and degradation products in bulk as well as in marketed formulations. newlineTemozolomide and Anastrozole are not official in any pharmacopoeia and not a single newlineanalytical method was reported for the simultaneous estimation of these drugs in the newlineformulation and Related compounds using the same method. newlineFor the present studies analytical methods based on Reversed Phase High Performance newlineLiquid Chromatography (RP-HPLC), and Mass Spectroscopy (LC-MS) have been newlinedeveloped. newlineFrom the Literature review it is unable to find the combined HPLC methods for their newlinerespective formulations of Temozolomide and Anastrozole are present in publications newlinehowever, an analytical methods for individual analysis for Temozolomide and newlineAnastrozole was published.%%%