TECHNIQUES OF QUANTITATIVE DETERMINATION OF CIPROFLOXACIN AND OXYTOCIN IN THE NOVEL PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF PURULENT AND INFLAMMATORY WOUNDS AND THEIR VALIDATION

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Issue: 
1
Year: 
2017

A.A. Tumashov
Ph.D. (Chem.), Associate Professor, Department of Organic Chemistry, Institute of Natural Sciences, Ural Federal University;
Senior Research Scientist, Laboratory of Asymmetric Synthesis,
I.Ya. Postovsky Institute of Organic Synthesis of Ural Branch of RAS (Ekaterinburg)
M.V. Ivanenko
Ph.D. (Chem.), Research Scientist, Laboratory of Organic Materials,
I.Ya. Postovsky Institute of Organic Synthesis of Ural Branch of RAS (Ekaterinburg)
E-mail: mariav.ivanenko@gmail.com
I.N. Shtan’ko
Ph.D. (Pharm.), Junior Research Scientist, Laboratory of Organic Materials,
I.Ya. Postovsky Institute of Organic Synthesis of Ural Branch of RAS (Ekaterinburg)
T.G. Khonina
Dr.Sc. (Chem.), Leading Research Scientist, Laboratory of Organic Materials,
I.Ya. Postovsky Institute of Organic Synthesis of Ural Branch of RAS (Ekaterinburg)
N.B. Perunova
Dr.Sc. (Med.), Head of Laboratory of Biomonitoring and Molecular Genetic Studies,
Institute of Cellular and Intracellular Symbiosis of Ural Branch of RAS (Orenburg)

We have previously proposed the medicine for local treatment of suppurating wounds in the form of pharmaceutical composition, containing oxytocin and ciprofloxacin as the active drugs and silicon-containing glycerohydrogel Si(C3H7O3)4·6C3H8O3·24H2O as the base. It was shown that the medicine is non-toxic, it possesses wound-healing and regenerative activity, and it prevents the occurrence of septic complications. In this work the techniques of quantitative determination of active components of the medicine (ciprofloxacin and oxytocin), based on their exhaustive extraction by water (in the case of ciprofloxacin) and by a mixture of glacial acetic acid and 96% ethyl alcohol (in the case of oxytocin) were developed. UV spectroscopy was proposed for quantitative determination of ciprofloxacin in the medicine, HPLC – for oxytocin. Methods were adapted to the new dosage form containing both ciprofloxacin and oxytocin. Calculation of the metrological characteristics and validation of the procedures were carried out for three samples of model systems in five parallel determinations (for each procedure) in terms of such parameters as specificity, analytical region, linearity, accuracy and precision. Calculations and validation were also performed on two «placebo» mixtures that did not contain ciprofloxacin, in one case, and oxytocin, in another. The determined validation characteristics confirm the validity of techniques for quantitative determination of ciprofloxacin and oxytocin. The techniques may be recommended for inclusion in the normative and technical documentation for the standardization and possible implementation of the medicine in medicinal practice.ng psychotropic activity were identified among the synthesized compounds.

Keywords: 
Key words: ciprofloxacin
oxytocin
pharmaceutical composition
quantitative determination
ultraviolet spectroscopy
high performance liquid chromatography
validation.

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