INTER-COMPANY CROSS-VALIDATION EXERCISE ON CAPILLARY ELECTROPHORESIS - QUANTITATIVE-DETERMINATION OF DRUG COUNTERION LEVEL

被引：29

作者：

ALTRIA, KD

CLAYTON, NG

HARDEN, RC

MAKWANA, JV

PORTSMOUTH, MJ

机构：

[1] PFIZER LTD, SANDWICH, KENT, ENGLAND

[2] RHONE POULENC RORER LTD, DAGENHAM, ENGLAND

[3] LILLY RES CTR LTD, WINDLESHAM GU20 6PH, SURREY, ENGLAND

[4] BOOTS CO, NOTTINGHAM, ENGLAND

[5] FISONS PHARMACEUT, LOUGHBOROUGH, LEICS, ENGLAND

来源：

CHROMATOGRAPHIA | 1995年 / 40卷 / 1-2期

关键词：

CAPILLARY ELECTROPHORESIS; QUANTITATIVE DETERMINATION; SODIUM; CEPHALOTHIN;

D O I：

10.1007/BF02274607

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A capillary electrophoresis (CE) method for the quantitative determination of sodium levels in the sodium salt of an acidic drug has been transferred across 6 independent pharmaceutical companies. All companies were able to demonstrate similar selectivity and acceptable precision for migration times and relative migration times. Five companies obtained acceptable precision for the repeatability of response factors from repeated injections of calibration solutions. Highly variable results from the sixth company indicated problems arising from contamination from residual sodium, possibly from unclean glassware or autosampler vials. The quantitative assay results from all companies confirmed the correct drug: counter-ion ratio. The average % w/w sodium content was 5.45% which represents 99.0% of the theoretical sodium content of sodium cephalothin

引用

页码：47 / 50

页数：4

共 13 条

[1] QUANTITATIVE-DETERMINATION OF DRUG COUNTERION STOICHIOMETRY BY CAPILLARY ELECTROPHORESIS
ALTRIA, KD
GOODALL, DM
ROGAN, MM
[J]. CHROMATOGRAPHIA, 1994, 38 (9-10) : 637 - 642
[2] INTER-COMPANY CROSS-VALIDATION EXERCISE ON CAPILLARY ELECTROPHORESIS .1. CHIRAL ANALYSIS OF CLENBUTEROL
ALTRIA, KD
HARDEN, RC
HART, M
HEVIZI, J
HAILEY, PA
MAKWANA, JV
PORTSMOUTH, MJ
[J]. JOURNAL OF CHROMATOGRAPHY, 1993, 641 (01): : 147 - 153
[3] AN INTER-COMPANY CROSS-VALIDATION EXERCISE ON CAPILLARY ELECTROPHORESIS TESTING OF DOSE UNIFORMITY OF PARACETAMOL CONTENT IN FORMULATIONS
ALTRIA, KD
CLAYTON, NG
HART, M
HARDEN, RC
HEVIZI, J
MAKWANA, JV
PORTSMOUTH, MJ
[J]. CHROMATOGRAPHIA, 1994, 39 (3-4) : 180 - 184
[4] ALTRIA KD, IN PRESS J PHARM BIO
[5] ALTRIA KD, IN PRESS LG CG
[6] CAPILLARY ELECTROPHORESIS OF ORGANIC AND INORGANIC CATIONS WITH INDIRECT UV DETECTION
BECK, W
ENGELHARDT, H
[J]. CHROMATOGRAPHIA, 1992, 33 (7-8) : 313 - 316
[7] BUCKBERGER W, 1992, J CHROMATOGR, V608, P59
[8] COUFAL P, 1994, HRC-J HIGH RES CHROM, V17, P325
[9] JANDIK P, 1991, LC GC-MAG SEP SCI, V9, P634
[10] VARIOUS APPROACHES TO ANALYSIS OF DIFFICULT SAMPLE MATRICES OF ANIONS USING CAPILLARY ION ELECTROPHORESIS
JONES, WR
JANDIK, P
[J]. JOURNAL OF CHROMATOGRAPHY, 1992, 608 (1-2): : 385 - 393

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