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SM ISO690:2012 UNCU, Livia, DONICI, Elena, VALICA, Vladimir, VÎSLOUH, Oxana, GONCIAR, Veaceslav, PARII, Sergiu. Development and validation of an assay method for ciprofloxacin hydrochloride determination in combination ear drops. In: Chemistry Journal of Moldova, 2019, nr. 2(14), pp. 56-61. ISSN 1857-1727. DOI: https://doi.org/10.19261/cjm.2019.607 |
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Chemistry Journal of Moldova | ||||||
Numărul 2(14) / 2019 / ISSN 1857-1727 /ISSNe 2345-1688 | ||||||
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DOI:https://doi.org/10.19261/cjm.2019.607 | ||||||
CZU: 543.42:[615.31+615.33] | ||||||
Pag. 56-61 | ||||||
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A simple, precise and accurate UV-Vis spectrophotometric method has been developed and validated for assaying ciprofloxacin hydrochloride in combination ear drops with basil oil (Ocimum basilicum). Ciprofloxacin hydrochloride presented an absorption maximum at 278 nm, while the placebo solution showed a very low absorption in the 220-400 nm range. The parameters of validation have been determined according to the International Conference of Harmonization guidelines „Q2R1: For Analytical Procedures and Validation”. Linearity was obtained over the concentration range 2-10 μg/mL with a correlation coefficient of 0.999. The value of the limit of detection was of 0.786 μg/mL and of the limit of quantification was of 2.383 μg/mL. The percentages of recovery of ciprofloxacin hydrochloride in combination ear drops exceeded 99.0%. The relative standard deviation values of precision and robustness were less than 2%. Short-term stability results showed that the samples were stable at room temperature for 24 hours. |
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Cuvinte-cheie ciprofloxacin hydrochloride, UV-Vis spectroscopy, validation, ear drop, Ocimum basilicum |
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