Development and validation of a HPLC method for the determination of metronidazole, oxytetracycline and furazolidone in veterinary formulations

Authors: Violeta Tauber (Giugiu), Viorica Chiurciu
Affiliation: Romvac Company S.A.

An isocratic reversed phase high performance liquid chromatographic method with DAD detection was developed for the analysis of metronidazole, oxytetracycline and furazolidone. The mobile phase consisted of pH 2.5 phosphate buffer solution, methanol and acetonitrile (70 : 18 : 12). The UV detection was carried out at 264 nm, and the flow rate was 1.100 mL / min. The separation was carried out on a Nucleosil C18 column, 5 μm 250 mm x 4.6 mm, which was maintained at 25°C. This method was validated by system suitability parameters, linearity, limits of detection and quantification, precision and accuracy.

full text

Forced degradation of metronidazole, oxytetracycline and furazolidone studies using High Performance Liquid Chromatography

Authors: Violeta Tauber (Giugiu), Viorica Chiurciu
Affiliation: Romvac Company S.A.

The study describes the development of a HPLC-DAD method for the estimation of oxytetracycline and furazolidone in Enteroguard M – powder. The proposed method utilizes a Betasil C 18 column, (4.6 x 250 mm, 5 μm), at 300 °C, optimum mobile phase consisted of 40 mM phosphate buffer (pH = 7.5): methanol in gradient elution. The flow rate was optimized to 1mL / min and the detection was carried at 254 nm. The drug substance was exposed to temperature, light, oxidants, acid and basic hydrolysis, and the resultant samples were analyzed by the proposed method.

full text

A validated HPLC method for determination of furazolidone and oxytetracycline in the presence of related substances

Author: Violeta Giugiu                                                                                                                       Affiliation: Romvac Company S.A., Bucharest

The objective of the current study was to develop a simple, precise, rapid and accurate reverse phase liquid chromatographic method for the quantitative determination on furazolidone, oxytetracycline and related substances in veterinary formulation. This formulation was submitted to accelerated degradation studies under acidic, alkaline and oxidative conditions, exposure to light and thermal stability. The separation of furazolidone, oxytetracycline and degradation products was achieved on BDS Hypersil C18 (250mmx4.6mm, i.d. 5 µm particle size) with gradient mobile phase containing methanol and 80 mM dipotassium phosphate pH 7,5 (20/80). The flow rate was 1.0 mL/min and detection was set at 254 nm, at 25 °C. The developed method was validated with respect to linearity, limits of detection and quantification, specificity, accuracy, and precision.

full text

Development and validation of a RP- HPLC method for the quantittation studies of metronidazole and furazolidone from product Enteroguard M

Authors: Elena Gabriela Oltean1, Milea B.2

Affiliation: 1 Romvac Company SA,                                                                                                                                                                          2 Proanalysis Systems SRL

An isocratic high-performance liquid chromatography (HPLC) procedure was developed for quantitative determination of metronidazole and furazolidone in tablet dosage forms of ENTEROGUARD M. HPLC separation was carried out by reversed phase chromatography Kromasil C18 (250 mm x 4,6 mm i.d.; 5 +m particle size), held at 25°C. The mobile phase consisted of methanol/ 0,1% phosphoric acid aq. (20/ 80 v/ v), run at flow rate of 1 mL/ min and with UV detection at 317 nm. Method validation investigated parameters such as linearity (r2 = 0. 9999), range, precision, accuracy and specificity. The described method can be successfully applied for the analysis of ENTEROGUARD M tablets.

 full text (in Romanian)