000			a
999			_c15689 _d15689
003			OSt
005			20211222121859.0
008			211222b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_914964 _a Pandey, Swati
245			_aAppliance of the ICH Guidelines: Forced Degradation Studies on Abafungin and Development of Validated Stability Indicating Method by 1st Order Derivative Spectroscopy
250			_aVol.55(1), Jan_Mar
260			_aKarnataka _bAssociation of Pharmaceutical Teachers of India (APTI) _c2021
300			_a249-255p.
520			_aBackground: The presented study is a stability indicating simple, precise and accurate 1st order UV derivative spectroscopic method that is being studied under the different stated International Council for Harmonization (ICH) Guidelines for the forced degradation and establishes a validated method for Abafungin and its main degradants in the active pharmaceutical ingredients (API) and the marketed formulations. Materials and Methods: Adhering to the ICH guidelines the analytical parameters viz. linearity, range, precision, recovery, robustness and ruggedness were validated. The method was based on thorough stress testing with acid, base, thermal, photolytic and oxidative degradations. Results: It was found that a linear response is present in the concentration range of 5-50 μg/mL at 242 nm. The % relative standard deviation (RSD) for precision studies of Intraday and Interday were <1.2% and <1.9% respectively. Conclusion: The appropriateness of the developed method was tested by analyzing the marketed cream of Abafungin and the thorough forced degradations studies was able to predict the stability of Abafungin in the marketed formulation. The method is found to be unambiguous to both the drug and its degradants.
650		0	_94639 _aPHARMACEUTICS
700			_914966 _aPandey, Ravindra
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_55_1_249.pdf _yClick here
942			_2ddc _cAR