An HPTLC method for the determination and the purity control of ciprofloxacin HCl in coated tablets

被引：39

作者：

Novakovic, J

Nesmerak, K

Nova, H

Filka, K

机构：

[1] Charles Univ, Dept Analyt Chem, Fac Sci, CR-12840 Prague 2, Czech Republic

[2] PRO MED CS, Qual Control Lab, Prague 14000 4, Czech Republic

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2001年 / 25卷 / 5-6期

关键词：

ciprofloxacin hydrochloride coated tablets; HPTLC; quantitative analysis; purity control; method validation; HPTLC versus HPLC; ANOVA; t-test;

D O I：

10.1016/S0731-7085(01)00387-9

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A high-performance thin-layer chromatographic method (HPTLC) has been developed for the determination and the purity control of a synthetic fluoroquinolone antibiotic ciprofloxacin hydrochloride in coated tablets when desfluoro compound. ethylene diamine compound, by-compound A and fluoroquinolonic acid are considered as impurities. Silica gel Fz,, was used as a stationary phase and a mixture of acetonitrile. ammonia 25%,. methanol and methylene chloride (1:2:4:4, v/v/v/v) as a mobile phase. The method was validated in terms of linearity (range). selectivity (placebo and related compounds), precision. accuracy (Recovery)- system suitability (repeatability. peak symmetry, resolution) and impurities limit of detection (LOD). The analysis of variance (ANOVA) and t-test were applied to correlate the results of ciprofloxacin hydrochloride determination in coated tablets by means of the HPTLC method acid the official British Pharmacopoeia (BP 1999) high-performance liquid chromatographic (HPLC) method. (C) 2001 Elsevier Science B.V. All rights reserved.

引用

页码：957 / 964

页数：8