Pharmaceuticals, Vol. 13, Pages 32: Gr?di?nt HPLC M?th?d f?r Simult?n??us D?t?rmin?ti?n ?f ?ight S?rt?n ?nd St?tin Drugs in Th?ir Pur? ?nd D?s?g? F?rms (Pharmaceuticals)

? gr?di?nt HPLC m?th?d was d?v?l?p?d ?nd v?lid?t?d f?r r?pid simult?n??us s?p?r?ti?n ?nd d?t?rmin?ti?n ?f the following eight drugs ?f s?rt?n ?nd st?tin cl?ss?s in th?ir pur? ?nd d?s?g? f?rms within 15 minutes: irb?s?rt?n (IRB), l?s?rt?n (L?S), v?ls?rt?n (V?L), ?lm?s?rt?n (?LM), r?suv?st?tin (R?S), ?t?rv?st?tin (?TR), l?v?st?tin (L?V), ?nd simv?st?tin (SIM). S?p?r?ti?n w?s c?rri?d ?ut ?n ? Kin?t?x C18 100? c?lumn (2.60 m, 4.60 mm × 100 mm) using ? gr?di?nt bin?r? m?bil? ph?s? ?f 0.05M p?t?ssium dih?dr?g?n ph?sph?t? buff?r (pH 3.50 ?djust?d b? ?rth?-ph?sph?ric ?cid) ?nd ?c?t?nitril? ?t r??m t?mp?r?tur?. Th? fl?w r?t? w?s 1.00 mL/min ?nd m?ximum ?bs?rpti?n w?s m??sur?d using a D?D d?t?ct?r ?t 280 nm. Th? r?t?nti?n tim?s ?f IRB, L?S, R?S, V?L, ?TR, L?V, ?LM, ?nd SIM w?r? r?c?rd?d t? b? 4.72, 5.32, 6.06, 7.19, 7.96, 9.30, 11.91, ?nd 14.66 minut?s, r?sp?ctiv?l?. Limits ?f d?t?cti?n w?r? r?p?rt?d t? b? 2.01, 1.32, 1.10, 0.76, 0.21, 1.50, 0.38, ?nd 0.55 mM f?r th? s?m? s?qu?nc? ?f drugs, r?sp?ctiv?l?, sh?wing ? high d?gr?? ?f m?th?d s?nsitivit?. Th? m?th?d w?s th?n v?lid?t?d ?cc?rding t? the int?rn?ti?n?l c?nf?r?nc? ?f h?rm?niz?ti?n (ICH) guid?lin?s f?r th? d?t?rmin?ti?n ?f th? drugs in th?ir d?s?g? f?rms with highl? pr?cis? r?c?v?ri?s. ?ls?, a st?tistic?l c?mp?ris?n with r?f?r?nc? m?th?ds w?s p?rf?rm?d sh?wing n? signific?nt diff?r?nc?s b?tw??n th? pr?p?s?d m?th?d ?nd r?p?rt?d ?n?s in t?rms ?f pr?cisi?n ?nd ?ccur?c?.