Analysis of Paracetamol, Pseudoephedrine and Brompheniramine in Comtrex® Tablets Using Chemometric Methods

Youssef, Souha H.

doi:10.20959/wjpps20176-9410

Cited by 3 publications

(1 citation statement)

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“…The separation of these ingredients in the pharmaceutical dosage forms is difficult due to similarities of their physical and chemical properties. Thus, our aim was to conduct different sensitive, accurate and precise chromatographic methods (TLC, HPLC–UV and UPLC-MS/MS) for the separation and quantitation of PAR, PSE and BRM in their combined dosage form specifically as to the extent of our knowledge; from a detailed literature survey that only one chemometric method [28] was reported for their simultaneous determination. In addition, was to demonstrate the privileges introduced by each method and to conduct statistical comparison between the newly developed methods and reported ones to assure the applicability of our methods for their intended use.…”

Section: Introductionmentioning

confidence: 99%

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

et al. 2019

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Comtrex ® tablets composed of paracetamol, pseudoephedrine and brompheniramine are widely used for relieving symptoms related to common cold. This study has overcome the challenging dosage form ratio (250:15:1) and proposed chromatographic methods for analyzing the ternary combination were utilized displaying different apparatus, solvents and sensitivity ranges. Three chromatographic methods namely thin layer chromatography (TLC), high performance liquid chromatography with ultra-violet detection (HPLC–UV) and ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) were developed and validated for the simultaneous determination of the three drugs. Concerning the TLC method, aluminum TLC plates pre-coated with silica gel 60F 254 were used and methanol:water:ammonia (9:1:0.1, v/v/v) was applied as a mobile phase; scanning of the plates was carried out at 254 nm. For the HPLC–UV method C 18 column was used with an isocratic elution mobile phase composed of water:acetonitrile (75:25, v/v; pH 3.2) and the detection was at 210 nm. For the UPLC-MS/MS method; separation was performed on a UPLC-BEH C 18 column with methanol: 0.1% ammonium formate (60:40, v/v) as the mobile phase utilizing diphenhydramine as an internal standard and mass spectrometry was used for detection. The methods were simple, sensitive, accurate and precise. Statistical analysis revealed no significant difference from the reported methods in regard to accuracy and precision. Electronic supplementary material The online version of this article (10.1186/s13065-019-0595-6) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

et al. 2019

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Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation

Soliman

Mostafa

Fayez

et al. 2022

Journal of AOAC INTERNATIONAL

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Background Common cold and cough preparations represent a huge segment of global pharmaceutical market. Recently, cold/cough formulations containing Paracetamol (PAR) have attracted a significant attention due to PAR has been implemented into the supportive treatment of COVID-19 mild cases as the first line antipyretic. According to the literature review, no method has been reported yet for simultaneous estimation of PAR, Pseudoephedrine hydrochloride (PSE) and Carbinoxamine maleate (CRX) in any matrices. Thus, there is an urgent need for smart, and green methods that would enable quantification of the cited components in their desperate ratio. Objectives The 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. Methods Namely, the proposed methods are: direct spectrophotometry, dual wavelength, first derivative, derivative ratio, ratio difference, constant center coupled with spectrum subtraction, and constant multiplication method paired with spectrum subtraction. Results These 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 ICH guidelines. The obtained results were statistically benchmarked to the official ones where no significant difference was noticed. Conclusion The developed methods are successfully applied for concurrent quantification of 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 AGREE algorithm based on the green analytical chemistry framework, GAPI, Eco-Scale, AGP, and NEMI. Highlights Green spectrophotometric methods on simultaneous quantification of PAR, PSE and CRX for the first time. These approaches incorporate simple enrichment-aided technique to augment their spectrophotometric signals facilitating the accurate quantitation of the minor component in the cited mixture.

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Smart Chemometric-Assisted Spectrophotometric Approaches for Simultaneous Quantification of Tertiary Combination Recommended for COVID-19 Supportive Treatments With Their Greenness Assessment

Soliman,

Tantawy,

Mostafa

et al. 2024

Journal of AOAC International

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Background There is an increasing interest of scientific community in developing innovative methodologies for their analysis needs within green analytical chemistry framework. UV spectrophotometry is one of the most promising eco-friendly methods, which is integrated with advanced chemometric tools to enhance the selectivity of the analysis of complex mixtures with severe overlapped signals. Objectives Simultaneous determination of a triple-combination of pseudoephedrine hydrochloride (PSE), carbinoxamine maleate (CRX), and paracetamol (PAR) using an artificial intelligence system and multivariate calibration methods. This combination is recently recommended for COVID-19 home-treated patients as part of a symptomatic treatment. Methods Namely, the suggested models are: Artificial Neural Networks, Partial Least Squares, and Principal Component Regression. The proposed algorithms were optimized and developed with the aid of a five-level, three-factor experimental design. Results The investigated methods were applied over the concentration range of 100–180 μg/mL, 18–16 μg/mL, and 4–12 μg/mL for PSE, CRX, and PAR, respectively. The models validation results demonstrated excellent recoveries (around 98 to 102%), signaling the approaches outstanding resolution capacity for the cited compounds in the presence of common excipients. The outcomes of the studied methods were statistically compared to the official approaches, and no significant difference was found. Conclusion The suggested models were efficiently employed to determine the selected drugs in their combined tablets without any initial separation steps. The impact of these methods on the environment was evaluated via greenness tools, namely; National Environmental Method Index, Raynie and Driver’s green assessment method, analytical Eco-Scale, Green Analytical Procedure Index, and Analytical Greenness Metric. Highlights Green chemometric quality assessment of PSE, CRX, and PAR in their pure and pharmaceutical dosage forms. The established approaches are innovative, sustainable, smart, fast, selective, and cost-effective. These models are potential green nominees for routine analysis of the investigated mixture in quality control laboratories.

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Analysis of Paracetamol, Pseudoephedrine and Brompheniramine in Comtrex® Tablets Using Chemometric Methods

Cited by 3 publications

References 44 publications

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation

Smart Chemometric-Assisted Spectrophotometric Approaches for Simultaneous Quantification of Tertiary Combination Recommended for COVID-19 Supportive Treatments With Their Greenness Assessment

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