000			a
999			_c7760 _d7760
003			OSt
005			20181204152752.0
008			181204b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_96559 _aAnerao, A.
245			_aHPLC Determination of n-methylethanolamine in diphenhydramine hydrochloride drug substance by pre-
250			_aVol. 55 (10)
260			_aMumbai _bIndian Drug Manufacture's Association - IDMA _c2018
300			_a56-62
520			_aN-Methylethanolamine is the side chain of the drug diphenhydramine hydrochloride. A sensitive high performance liquid chromatography method with pre-column derivatization was developed and validated for the determination of N-methylethanolamine impurity in diphenhydramine hydrochloride active pharmaceutical ingredient. HPLC method on column Cosmosil MS-II, C-18, 250 mm X 4.6 mm, particle size 5 μm with UV detector was used. The proposed method is specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.03 mg/g to 1.5 mg/g and the correlation coefficient was 0.999. Method had very low limit of detection (LOD) and limit of quantification (LOQ) as 0.01 mg/g and 0.03 mg/g, respectively, of the analyte. Accuracy was observed within 94.4% to 96.2%.
650		0	_94639 _aPHARMACEUTICS
653			_aDerivatization _avalidation
700			_96561 _aDighe, V.
700			_96562 _aGupta, A.
773	0		_tIndian drugs _dMumbai Indian Drug Manufactures Association
942			_2ddc _cAR