000			01660nam a2200145 4500
008			251016b |||||||| |||| 00| 0 eng d
100			_aAbhishek Sharma
245			_aDEVELOPMENT OF A PRECOLUMN DERIVATIZATION METHOD FOR THE QUANTITATIVE DETECTION OF ETHYLENEDIAMINE IMPURITY IN PHARMACEUTICAL DRUGS USING RP-HPLC COUPLED WITH UV/PDA DETECTOR
300			_aPage No. 44-51
520			_aThe proposed study aimed to create and validate a technique for detecting impurities in drug substances, specifically targeting low levels of ethylenediamine in pharmaceutical raw materials. The method involved the use of benzoyl chloride as a derivatizing agent, during pre-column derivatization processing, effectively boosting the sensitivity and precision of the method. Chromatographic conditions were optimized, including the use of 0.7g L-1 di-sodium hydrogen phosphate anhydrous and methanol, a specific XBridgeTM Shield RP-18 column, 10μL injection volume, and a flow rate of 0.8mL min-1 at 25°C. This method combined precolumn derivatization with RP-HPLC UV/PDA detection, proving highly sensitive and precise with favorable linearity (r ≥ 0.99) and precision (% RSD/CV < 5.0) upon validation. The developed method is noted for its simplicity, speed, cost-effectiveness, and suitability for regular analysis in QC labs, particularly for detecting impurities in drug candidates.
654			_aEthylenediamine _areversed-phase _aHPLC _aValidation _aSpecificity _aprecision _asolution-stability
700			_aPankaj Garga
773	0		_0125265 _9114019 _dMumbai Indian Drugs Manufacturer's Association _tIndian Drugs _x0019-462X
942			_cJA
999			_c133045 _d133045