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Eurasian Journal of Analytical Chemistry
Volume 10, Issue 2 (September 2015), pp. 84-105

DOI: 10.12973/ejac.2015.107a

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Research Article

Published online on Sep 01, 2015

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Design of Experiment (DOE) Utilization to Develop a Simple and Robust RP-UPLC Technique for Stability Indicating Method of Ciprofloxacin Hydrochloride and Metronidazole in Tablets

Hany M Hafez, Abdalla A Elshanawane, Lobna M Abdelaziz, Mostafa S Mohram

Abstract

Ciprofloxacin Hydrochloride and Metronidazole are indicated for the treatment of intra-abdominal and pelvic infections caused by E. coli and diverticulitis. It is necessary to establish a Validated HPLC method for the assay of them. Using of DOE techniques provides more information about different factors affects system suitability of new method. DOE led to highly robust methods through creating design space.The method was performed on Phenomenex Kinetex C18 (50x4.6 mm, 2.6 µm) and the mobile phase consisted of triethylamine (TEA), (0.5 % v/v, pH 4.5) and acetonitrile which pumped at a flow rate 0.6 ml/min at 50 °C in gradient manner. 2 µl of drugs sample solutions were monitored at fixed wavelengths 320 nm.Ciprofloxacin Hydrochloride, Metronidazole and Caduet tablets bulk powders were stressed under different conditions in forced degradation studies. Major degradation products were identified such as 2-methyl-4-nitroimidazole, Fluoroquinolonic acid and Ciprofloxacin Ethylenediamine. The proposed method was validated in terms of linearity, accuracy, precision and limits of detection and quantitation according to ICH.

Keywords: Ciprofloxacin Hydrochloride; Metronidazole; UPLC; Stability Indicating Method; Design of Experiment


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