000			a
999			_c17630 _d17630
003			OSt
005			20220923144946.0
008			220923b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_918080 _aBharti, Amber
245			_aHPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient
250			_aVol.56(1), Jan-Mar
260			_aKarnataka _bAssociation of Pharmaceutical Teachers of India (APTI) _c2022
300			_a240-246p.
520			_aAim: The purpose of this research study, is to develop and validate a reverse phase HPLC test method for detecting relevant impurities in Testosterone cypionate (TCY). Materials and Methods: The chromatographic system for separation of related impurities were achieved in Zorbax XDB-C8 (15 cm x 4.6 mm), 5 micron HPLC column utilising gradient elution technique. Water was selected as solvent-A and Acetonitrile was preferred as solvent-B for mobile phase. The method is gradient technique. Column heater was kept constant at 35°C; the rate of flow was 1.2 mL per min; volume of injection was 20 μL and 240 nm was set for detector wavelength. Results: The % recovery was in the range of 95.6% to 108.7% for all impurities. The result of correlation coefficient were higher than 0.98. Testosterone is the major degradants obtained from forced degradation study. Conclusion: The created method can be utilise in quality control testing on a regular basis for the analysis of Testosterone cypionate.
650		0	_94639 _aPHARMACEUTICS
700			_918081 _a Kumbhare, Ravindra Motiram
773	0		_tIndian journal of pharmaceutical education and research _dBengluru Association of Pharmaceutical Teachers of India (APTI) _x0019-5464
856			_uhttps://www.ijper.org/sites/default/files/IndJPhaEdRes-56-1-240.pdf _yClick here
942			_2ddc _cAR