DETERMINATION OF THE IMMUNOSUPPRESSIVE DRUG TACROLIMUS IN ITS DOSAGE FORMS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

被引：15

作者：

NAMIKI, Y

FUJIWARA, A

KIHARA, N

KODA, S

HANE, K

YASUDA, T

机构：

[1] Analytical Research Laboratories, Fujisawa Pharmaceutical Co., Ltd., Osaka, 532, Yodogawa-ku

来源：

CHROMATOGRAPHIA | 1995年 / 40卷 / 5-6期

关键词：

COLUMN LIQUID CHROMATOGRAPHY; IMMUNOSUPPRESSIVE DRUG FK 506 (TACROLIMUS); TAUTOMERIC PHENOMENON;

D O I：

10.1007/BF02290354

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A high-performance liquid chromatographic (HPLC) method has been developed and validated for the determination of FK506, a new immunosuppressant, in bulk drug samples and dosage forms. Equilibration between FK506 (I) and its tautomeric compounds (II and III) was accomplished ''artificially'' in water-dehydrated alcohol (1:1) employed as an extraction solvent. After reaching equilibrium, separation of I, treated as the representative of equilibrated FK506, from its related substances was achieved by reversed-phase HPLC on a Cls column with water-isopropyl alcohol-tetrahydrofuran (5:2:2, v/v) as the mobile phase, and detection at 220 nm. Component I in dosage forms could be recovered satisfactorily and determined with good precision. The calibration graph was linear over the range 2-6 mu g for I.

引用

页码：253 / 258

页数：6

共 21 条

[1]

CHRISTIANS U, 1991, TRANSPLANT P, V23, P940

[2]

CHRISTIANS U, 1991, TRANSPLANT P, V23, P2741

[3]

FRIOB MC, 1991, TRANSPLANT P, V23, P2750

[4]

Hane K, 1992, IYAKUHIN KENKYU, V23, P33

[5]

HATANAKA H, 1988, J ANTIBIOT, V41, P1586, DOI 10.7164/antibiotics.41.1586

[6] PHYSICOCHEMICAL STUDIES OF BIOLOGICALLY-ACTIVE PEPTIDES BY LOW-TEMPERATURE REVERSED-PHASE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].

HENDERSON, DE ;

MELLO, JA .

JOURNAL OF CHROMATOGRAPHY, 1990, 499 :79-88

[7]

JOSHUA H, 1991, RAININ DYNAMAX R JUN, P3

[8]

KOBAYASHI M, 1991, TRANSPLANT P, V23, P2725

[9]

MIELKE DF, 1991, HELV CHIM ACTA, V74, P1027

[10] TAUTOMERIC PHENOMENON OF A NOVEL POTENT IMMUNOSUPPRESSANT (FK506) IN SOLUTION .1. ISOLATION AND STRUCTURE DETERMINATION OF TAUTOMERIC COMPOUNDS [J].

NAMIKI, Y ;

KIHARA, N ;

KODA, S ;

HANE, K ;

YASUDA, T .

JOURNAL OF ANTIBIOTICS, 1993, 46 (07) :1149-1155

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