article · BMC Chemistry
Spectrophotometric and chemometric methods were developed and validated for the simultaneous quantification of fluocinolone acetonide, ciprofloxacin hydrochloride, and the degradation product ciprofloxacin impurity-A in ternary mixtures. The techniques examined included univariate derivative methods, ratio spectra approaches, and multivariate chemometric models using partial least squares and artificial neural networks. Calibration graphs showed linearity across defined microgram-per-millilitre concentration ranges for all three substances. Validation followed International Council for Harmonisation guidelines and showed statistical agreement with official testing methods. The analytical protocols were successfully tested on pure powder samples as well as commercial pharmaceutical ear drops containing fluocinolone acetonide and ciprofloxacin hydrochloride, providing simple, green, and accurate options for multi-component quality control testing.
Reliable quality control of pharmaceutical formulations requires methods that can measure active ingredients alongside potential impurities without complex separation. Developing green, spectrophotometric and computational methods allows laboratories to conduct rapid, accurate, and low-waste testing of ear drops and similar multi-drug treatments, ensuring products meet safety standards while matching the performance of official testing protocols.
The methods could be adopted by pharmaceutical quality assurance and analytical testing laboratories for routine batch testing and impurity profiling of ear drop medications. Having been tested and validated on commercial ear drops and pure active ingredients according to International Council for Harmonisation guidelines, the approach appears applied and tested, offering an environmentally conscious alternative to traditional chromatographic assays for drug manufacturing quality control.
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Abstract Green, simple, accurate and robust univariate and chemometrics assisted UV spectrophotometric approaches have been adopted and validated for concurrent quantification of fluocinolone acetonide (FLU), ciprofloxacin HCl (CIP) together with ciprofloxacin impurity-A (CIP imp-A) in their ternary mixture. Double-divisor ratio spectra derivative (DDRD) method has been used for determination of FLU. On the other hand, the first (D 1 ) and second (D 2 ) derivative approaches have been applied for the quantification of CIP and CIP imp-A, respectively. For the ratio difference (RD), derivative ratio (DR), and mean centering of ratio spectra (MC) methods, CIP and its impurity A have been simultaneously determined. The acquired calibration plots were linear over the concentration range of 0.6–20.0 μg/mL, 1.0–40.0 μg/mL and 1.0–40.0 μg/mL for fluocinolone acetonide, ciprofloxacin HCl, and ciprofloxacin impurity-A, respectively. The chemometrics methods namely; partial least squares (PLS) and artificial neural networks (ANN) were used for the concurrent determination of the three adopted components via using twenty-five mixtures as calibration set and fifteen mixtures as validation one. The investigated approaches were validated in accordance with International Council for Harmonisation (ICH) guidelines, and statistically compared with the official ones. The proposed methods were acceptably applied to the examination of FLU and CIP in their pure powders and pharmaceutical ear drops.
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DOI: 10.1186/s13065-023-00963-w
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