8Basak A K, Raw A S, Al Hakim A H, et al. Pharmaceutical impurities:Regulatory perspective for abbreviated new drug applications [ J ]. Adv Drug Del Rev, 2007,59 ( 1 ) : 64-72.
9Hertzog D L, McCafferty J F, Fang X, et al. Development and validation of a stability-indicating HPLC method for the simultaneous determination of Losartan potassium, hydrochlorothiazide, and their degradation products [ J ]. J Pharm Biomed Anal,2002,30(3 ) :747-760.
10Persson-Stubberud K, Astrom O. Separation of ibuprofen, codeine phosphate, their degradation products and impurities by capillary electrophoresis Ⅰ. Method development and optimization with fractional factorial Design [ J ].J Chromatogr A, 1998,798 ( 1/2) : 307-314.