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Classical versus chemometrics tools for spectrophotometric determination of fluocinolone acetonide, ciprofloxacin HCl and ciprofloxacin impurity-A in their ternary mixture.

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 (D¹) and second (D²) 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.

SUBMITTER: Tantawy MA

PROVIDER: S-EPMC10249224 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Classical versus chemometrics tools for spectrophotometric determination of fluocinolone acetonide, ciprofloxacin HCl and ciprofloxacin impurity-A in their ternary mixture.

Tantawy Mahmoud A MA Wahba Israa A IA Saad Samah S SS Ramadan Nesrin K NK

BMC chemistry 20230607 1

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<sup>1</sup>) and second (D<sup>2</sup>) derivative approaches have been a ...[more]

PMID: 37287045

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Project description:Novel univariate and chemometrics-aided UV spectrophotometric methods were tailored to undergo the fundamentals of green and white analytical chemistry for the simultaneous estimation of a ternary mixture of olanzapine (OLA), fluoxetine HCL (FLU), and its toxic impurity 4-(Trifluoromethyl) phenol (FMP) without any prior separation. The dual-wavelength ratio spectrum univariate method was used to determine OLA and FLU in the presence of FMP in the range of (4-20) and (5-50) μg/ml, respectively. In compliance with the International Conference on Harmonization (ICH) standards, the technique was validated and established Remarkable accuracy (98-102%) and precision (< 2%) with limits of quantification (LOQs) of 0.432 and 2.002 μg/ml, respectively. Partial least squares (PLS) and artificial neural networks (ANNs) are chemometric methodologies that have advantages over the univariate method and use significant innovations employing Latin hypercube sampling (LHS), allowing the generation of a reliable validation set to guarantee the effectiveness and sustainability of these models. The concentration ranges used were (2-20), (2-20), and (5-50) μg/ml; for PLS, the LOQs were 0.602, 0.508, and 1.429 μg/ml, and the root mean square errors of prediction (RMSEPs) were 0.087, 0.048, and 0.159 for OLA, FMP, and FLU, respectively; and for ANNs, the LOQs were 0.551, 0.465, and 0.965 μg/ml, with RMSEPs of 0.056, 0.047, and 0.087 for OLA, FMP, and FLU, respectively. The developed methods yield a greener National Environmental Methods Index (NEMI) with an eco-scale assessment (ESA) score of 90 and a complementary Green Analytical Procedure Index (complex GAPI) in quadrants with an analytical greenness metric (AGREE) score of 0.8. The Red‒Green-Blue 12 algorithm (RGB 12) scored 88.9, outperforming on reported methods and demonstrating widespread practical and environmental approval. Statistical analysis revealed no noteworthy differences (P > 0.05) among the proposed and published techniques. Both pure powders and pharmaceutical capsules were analyzed via these methods.

Project description:BackgroundCommon cold and cough preparations represent a huge segment of the global pharmaceutical market. Recently, cold/cough formulations containing paracetamol (PAR) have attracted significant attention as PAR has been implemented into the supportive treatment of mild cases of COVID-19 as the first-line antipyretic. From a literature review, no method has been reported yet for simultaneous estimation of PAR, pseudoephedrine hydrochloride (PSE) and carbinoxamine maleate (CRX) in any matrix. Thus, there is an urgent need for smart and green methods that would enable quantification of the cited components in their challenging ratio.ObjectivesThe aim of this work is to develop and validate the first UV spectrophotometric methods for simultaneous determination of the selected drugs taking into consideration the list of challenges including the highly overlapping features and spectral interferences in the cited mixture.MethodsNamely, the proposed methods are: direct spectrophotometry, dual wavelength, first derivative, derivative ratio, ratio difference, constant center coupled with spectrum subtraction, and the constant multiplication method paired with spectrum subtraction.ResultsThese methods were linear over the concentration range of 2.5-35 μg/mL, 1.5-20 μg/mL, and 4.5-35 μg/mL for PAR, PSE and CRX, respectively. These methods fulfill the validity parameters according to International Conference on Harmonization (ICH) guidelines. The results obtained were statistically benchmarked to the official ones where no significant difference was noticed.ConclusionThe developed methods are successfully applied for concurrent quantification of the studied components in the marketed dosage form without interference from matrix excipients. The impact on the environment was assessed by five green metrics, namely a recent Analytical greenness (AGREE) metric algorithm based on the green analytical chemistry framework, Green Analytical Procedure Index (GAPI), Eco-Scale, Assessment of Green Profile (AGP), and National Environmental Methods Index (NEMI).HighlightsEco-friendly and successive spectrophotometric methods were firstly developed in this work, for the simultaneous quantification of PAR, PSE and CRX. These approaches incorporate a simple enrichment-aided technique to augment their spectrophotometric signals, facilitating the accurate quantitation of the minor component in the cited mixture.

Dataset Information

Classical versus chemometrics tools for spectrophotometric determination of fluocinolone acetonide, ciprofloxacin HCl and ciprofloxacin impurity-A in their ternary mixture.

Publications

Classical versus chemometrics tools for spectrophotometric determination of fluocinolone acetonide, ciprofloxacin HCl and ciprofloxacin impurity-A in their ternary mixture.

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