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An HPTLC Method for the Determination and the Purity Control of Ciprofloxacin HCl in Coated Tablets

An HPTLC Method for the Determination and the Purity Control of Ciprofloxacin HCl in Coated Tablets

J Novakovic, K Nesmerak, H Nova, K Filka

J Pharm Biomed Anal. 2001 Jul;25(5-6):957-64.

PMID: 11377079

Abstract:

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 F254 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 and the official British Pharmacopoeia (BP 1999) high-performance liquid chromatographic (HPLC) method.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP526204104	Ciprofloxacin Related Compound A		526204-10-4	Price

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