Abstract
Objective: To develop and validate a reverse phase high performance liquid chromatographic method for simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on reverse phase Discovery Inertsil ODS3V Column, C18 (250 mm, 4.6 mm, 5 µm). The separation was achieved by employing the mobile phase consists of phosphate buffer (pH 4) and acetonitrile (40:60). The flow rate was 1.0 ml/min, at a detection wavelength of 295 nm. The proposed method was validated as per the International Council for Harmonisation (ICH) guidelines.Results: The retention time for ciprofloxacin and fluocinolone acetonide was found at 3.627 min and 5.037 min respectively. The proposed method was validated for specificity, accuracy, precision, linearity, the limit of detection (LOD), limit of quantitation (LOQ) and robustness. All validation parameters were within the acceptable range. The assay method was linear and found in the range from 12.5–37.25 µg/ml for ciprofloxacin and 0.625–1.875 µg/ml of fluocinolone acetonide. The relative standard deviation (RSD) values for ciprofloxacin and fluocinolone acetonide were 0.25 % and 0.18 %, respectively. Conclusion: A rapid, accurate and precise RP-HPLC method was developed for the simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and ointment formulation. The developed method was validated for specificity, accuracy, precision, linearity, the limit of detection, limit of quantitation and robustness according to ICH guidelines.
Highlights
Ciprofloxacin is a broad-spectrum antibiotic of the fluoroquinolone class, which is used to treat wide variety of infections
Various combinations of mobile phase and stationary phase were tested in an attempt to obtain the best resolution for ciprofloxacin and fluocinolone acetonide, which lead to the optimization of chromatographic conditions for the estimation of ciprofloxacin and fluocinolone acetonide in the pharmaceutical dosage form
The mobile phase consisting of phosphate buffer whose pH adjusted to 4 with orthophosphoric acid and acetonitrile (40:60 %v/v), pumped at a flow rate of 1.0 ml/min, was chosen for method development and validation of ciprofloxacin and fluocinolone acetonide by RP-HPLC method
Summary
Ciprofloxacin (fig. 1) is a broad-spectrum antibiotic of the fluoroquinolone class, which is used to treat wide variety of infections. 1) is a broad-spectrum antibiotic of the fluoroquinolone class, which is used to treat wide variety of infections It is chemically 1-cyclopropyl-6-fluoro-4-oxo-7(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid and its molecular weight is 331.347 g/mol. 2) is a topical steroid used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, seborrhea and psoriasis It is chemically 4aS, 4bR, 5S, 6aS, 6bS, 9aR, 10aS, 10bS, 12S)-4b,12difluoro-5-hydroxy-6b-(2-hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a, 4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho [2',1' :4,5] indeno[1,2-d][1,3]dioxol-2-one and its molecular weight is 452.488 g/mol. No analytical method has been reported for the simultaneous estimation of ciprofloxacin and fluocinolone acetonide. It was thought appropriate to develop a simple RP-HPLC method for the simultaneous estimation of ciprofloxacin and fluocinolone acetonide
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