LIQUID-CHROMATOGRAPHIC METHODS VALIDATION FOR PHARMACEUTICAL PRODUCTS

被引:25
作者
WILSON, TD
机构
[1] Sterling Research Group, Rensselaer
关键词
LC; methods validation; review;
D O I
10.1016/0731-7085(90)80066-X
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
The current status of validation in LC methods for the analysis of pharmaceuticals has been reviewed with special reference to compatibility testing methods. Validation data were provided in terms of method linearity, accuracy, precision, system suitability, specificity, use of alternate methods, injection order, application of peak height or area measurements and of internal or external standards. © 1990.
引用
收藏
页码:389 / 400
页数:12
相关论文
共 131 条
[1]   A SIMULTANEOUS ASSAY OF THEOPHYLLINE, EPHEDRINE HYDROCHLORIDE AND PHENOBARBITAL IN SUSPENSIONS AND TABLETS FORMULATIONS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
ALVI, SU ;
CASTRO, F .
JOURNAL OF LIQUID CHROMATOGRAPHY, 1986, 9 (10) :2269-2279
[2]   A STABILITY-INDICATING SIMULTANEOUS ANALYSIS OF ACETAMINOPHEN AND HYDROCODONE BITARTRATE IN TABLETS FORMULATION BY HPLC [J].
ALVI, SU ;
CASTRO, F .
JOURNAL OF LIQUID CHROMATOGRAPHY, 1987, 10 (15) :3413-3426
[3]   NITROGLYCERIN COMPATIBILITY WITH INTRAVENOUS FLUID FILTERS, CONTAINERS, AND ADMINISTRATION SETS [J].
BAASKE, DM ;
AMANN, AH ;
WAGENKNECHT, DM ;
MOOERS, M ;
CARTER, JE ;
HOYT, HJ ;
STOLL, RG .
AMERICAN JOURNAL OF HOSPITAL PHARMACY, 1980, 37 (02) :201-205
[4]   DETERMINATION OF FLURBIPROFEN IN DOSAGE FORM AND IN BIOLOGICAL-FLUIDS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
BABHAIR, SA .
JOURNAL OF LIQUID CHROMATOGRAPHY, 1988, 11 (02) :463-473
[5]   STABILITY OF CIMETIDINE HYDROCHLORIDE IN A TOTAL NUTRIENT ADMIXTURE [J].
BAPTISTA, RJ ;
PALOMBO, JD ;
TAHAN, SR ;
VALICENTI, AJ ;
BISTRIAN, BR ;
ARKIN, CF ;
BLACKBURN, GL .
AMERICAN JOURNAL OF HOSPITAL PHARMACY, 1985, 42 (10) :2208-2210
[6]   HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC SEPARATION OF THE DIASTEREOISOMERS OF PROPOXYPHENE - DETERMINATION OF MICROQUANTITIES OF BETA-DL-PROPOXYPHENE IN COMMERCIAL PREPARATIONS OF ALPHA-D-PROPOXYPHENE [J].
BARKAN, S ;
WAINER, IW .
JOURNAL OF CHROMATOGRAPHY, 1982, 240 (02) :547-551
[7]  
BEAULIEU N, 1986, J ASSOC OFF ANA CHEM, V69, P167
[8]   ASPECTS OF THE DEGRADATION KINETICS OF DAUNORUBICIN IN AQUEOUS-SOLUTION [J].
BEIJNEN, JH ;
VANDERHOUWEN, OAGJ ;
VOSKUILEN, MCH ;
UNDERBERG, WJM .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1986, 31 (1-2) :75-82
[9]   ASPECTS OF THE DEGRADATION KINETICS OF DOXORUBICIN IN AQUEOUS-SOLUTION [J].
BEIJNEN, JH ;
VANDERHOUWEN, OAGJ ;
UNDERBERG, WJM .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1986, 32 (2-3) :123-131
[10]   STABILITY-INDICATING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC ANALYSIS OF TRIMETHOPRIM IN PHARMACEUTICALS [J].
BERGH, JJ ;
BREYTENBACH, JC .
JOURNAL OF CHROMATOGRAPHY, 1987, 387 :528-531