Optimization and validation of a CZE method for rufloxacin hydrochloride determination in coated tablets.

Abstract:

:A simple and rapid capillary electrophoresis method with UV detection was developed and validated for the determination of rufloxacin hydrochloride in coated tablets. An experimental design strategy (Doehlert design and desirability function) allowed the analytical parameters to be simultaneously optimized in order to determine rufloxacin hydrochloride with high peak area/migration time ratio, good efficiency and short analysis time. Optimized analyses were run using boric acid 0.10 M adjusted to pH 8.8 as BGE and setting voltage and temperature at 18 kV and 27 degrees C, respectively. Pefloxacin mesylate was used as internal standard and run time was about three minutes. The method was validated for the drug substance and the drug product according to the ICH3 guidelines. Robustness was tested by experimental design using an eight-run Plackett-Burman matrix.

journal_name

J Pharm Biomed Anal

authors

Furlanetto S,Orlandini S,Porta EL,Coran S,Pinzauti S

doi

10.1016/s0731-7085(02)00054-7

subject

Has Abstract

pub_date

2002-06-15 00:00:00

pages

1161-71

issue

6

eissn

0731-7085

issn

1873-264X

pii

S0731708502000547

journal_volume

28

pub_type

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