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Spectrophotometric Methods for Simultaneous Determination of Oxytetracycline HCl and Flunixin Meglumine in Their Veterinary Pharmaceutical Formulation.

ABSTRACT: Four precise, accurate, selective, and sensitive UV-spectrophotometric methods were developed and validated for the simultaneous determination of a binary mixture of Oxytetracycline HCl (OXY) and Flunixin Meglumine (FLU). The first method, dual wavelength (DW), depends on measuring the difference in absorbance (ΔA 273.4-327 nm) for the determination of OXY where FLU is zero while FLU is determined at ΔA 251.7-275.7 nm. The second method, first-derivative spectrophotometric method (1D), depends on measuring the peak amplitude of the first derivative selectively at 377 and 266.7 nm for the determination of OXY and FLU, respectively. The third method, ratio difference method, depends on the difference in amplitudes of the ratio spectra at ΔP 286.5-324.8 nm and ΔP 249.6-286.3 nm for the determination of OXY and FLU, respectively. The fourth method, first derivative of ratio spectra method (1DD), depends on measuring the amplitude peak to peak of the first derivative of ratio spectra at 296.7 to 369 nm and 259.1 to 304.7 nm for the determination of OXY and FLU, respectively. Different factors affecting the applied spectrophotometric methods were studied. The proposed methods were validated according to ICH guidelines. Satisfactory results were obtained for determination of both drugs in laboratory prepared mixture and pharmaceutical dosage form. The developed methods are compared favourably with the official ones.

SUBMITTER: Merey HA

PROVIDER: S-EPMC5546081 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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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, 1.5-20, 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.

Project description:Considering the green chemistry perspective and improving the environmental impact of quality control labs; two direct techniques with less hazardous solvents, less waste production and less energy consumption were developed for simultaneous analysis of Aspirin and Metoclopramide in bulk powder and pharmaceutical formulation. The ratio between the two drugs in their co-formulated preparation is very challenging; (90: 1, Aspirin: Metoclopramide). The first technique is spectrophotometry using simple mathematical operations; ratio difference and derivative ratio-zero crossing. The second technique is high-performance thin-layer chromatography (HPTLC) -densitometry which used a mobile phase consisting of cyclo-hexane: methanol: methylene chloride in a ratio of (1:4:1, v/v/v). The greenest solvents which give acceptable resolution were chosen. Following the International Conference on Harmonization (ICH) guidelines, the methods were found to be accurate, precise, and selective. Those methods were statistically compared to the reported spectrophotometric method and the results proved that there is no significant difference in accuracy and precision. Furthermore, the developed methods were assessed using the Analytical Eco-scale, Green Analytical Procedure Index (GAPI) and the Analytical Greenness calculator (AGREE), which gave a full image about their greenness profile. The spectrophotometry was found to be an excellent green technique compared to HPTLC with was considered an acceptable green one. The developed HPTLC-densitometric method was used for the first time for the analysis of this binary mixture. The two proposed spectrophotometric methos have advantages over the published methods as they used easy manipulation steps and are applied on the market pharmaceutical formulation. Owing to the advantages of the developed techniques; being green, do not require expensive sophisticated equipment or large volume of solvents; they could be used for routine analysis in quality control aspects.

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Spectrophotometric Methods for Simultaneous Determination of Oxytetracycline HCl and Flunixin Meglumine in Their Veterinary Pharmaceutical Formulation.

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