Green Analytical Chemistry, Opportunities for Pharmaceutical Quality Control

Eldin, Ahmed Badr; Ismaiel, Omnia A.; Hassan, Waffa; Shalaby, Abdalla

doi:10.2139/ssrn.2791108

Cited by 8 publications

(8 citation statements)

References 28 publications

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“…Further knowledge of purity and processing requirements prior to subsequent atropine crystallisation from this aqueous stream will inform further CPM development. Validity of the optimal design and operating parameters presented here are for the stated plant capacities, solvent recoveries and LLE solvent choices; implementation of process analytical technology (PAT) is essential to ensure optimal process design results presented here to realise their cost optimal benefits for successful CPM implementation (Eldin et al, 2016;Yu and Kopcha, 2017 small scale applications) and countercurrent (economical solvent usage) flow arrangements has not been considered here but can further elucidate CPM benefits for atropine production. Splitting the PFR-2 effluent into multiple feeds for separate LLE tanks is also a possibility that would provide additional operational flexibility; consideration of these design variations in future work will further clarify potential promising operating configurations for atropine CPM.…”

Section: Figurementioning

confidence: 99%

Process modelling, design and technoeconomic Liquid–Liquid Extraction (LLE) optimisation for comparative evaluation of batch vs. continuous pharmaceutical manufacturing of atropine

Diab

Mytis

Boudouvis

et al. 2019

Computers & Chemical Engineering

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Continuous Pharmaceutical Manufacturing (CPM) can revolutionise industrial efficiency via potential operational and economic benefits over currently dominant batch methods. Process modelling and optimisation are valuable towards rapid design space evaluation and elucidation of optimal process design configurations, without expensive and time-consuming experimental campaigns. This paper pursues total cost minimisation via nonlinear optimisation of different separation design options for atropine, a product of great societal importance. The study considers a demonstrated continuous flow synthesis, presents reaction kinetic parameter estimation towards reactor design, and illustrates a comparative analysis of the subsequent batch vs. continuous Liquid-Liquid Extraction (LLE) for product purification, using published partition coefficient data and UNIFAC-modelled ternary liquidliquid equilibria. Original optimisation results show that toluene is the best continuous LLE solvent, attaining the lowest total costs at both plant capacities considered and the greatest total cost savings with respect to batch LLE design for varying solvent recovery, at acceptable material efficiencies.

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Section: Figurementioning

confidence: 99%

Process modelling, design and technoeconomic Liquid–Liquid Extraction (LLE) optimisation for comparative evaluation of batch vs. continuous pharmaceutical manufacturing of atropine

Diab

Mytis

Boudouvis

et al. 2019

Computers & Chemical Engineering

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show abstract

“…Contemporary requirements of quality control laboratories match principles of green chemistry, which imply development, and further implementation of rapid analyzes for quality control [13][14][15][16][17][18]. Consequently, analytical method development of new drug products requires a thorough assessment of simultaneous determination of all substances to be analyzed by one injection, prioritizing rapid methods, which at the same time are less harmful to the environment.…”

Section: Fig 3: Chemical Structure Of Metholmentioning

confidence: 99%

Simultaneous Determination of Benzydamine Hydrochloride, Methylparaben and Peppermint Oil in a Spray Dosage Form by Gas Chromatography

Chornyi¹,

Georgiyants

Gureeva³

et al. 2019

Int J App Pharm

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Objective: To develop and validate an analytical procedure for simultaneous determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form by gas chromatography method (GC). Methods: The analytical method was conducted on Agilent 7890 gas chromatograph, equipped with HP-5 capillary column with helium as a mobile phase, split/splitless injector and flame ionization detector and an auto injector. Validation parameters, such as selectivity, linearity, precision, accuracy and, robustness were estimated. Results: A method for simultaneous determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form by GC was developed. The retention time of menthol (marker substance of peppermint oil) methylparaben and benzydamine hydrochloride, was 5.0, 9.2, and 19.4 respectively. Relative standard deviation (RSD)% for precision was 0.24, 0.13 and 0.12 respectively. The linearity of the method for given analytes was estimated in a concentration range of 80-120% to a nominal concentration with the respective correlation coefficients of more than 0.999. Accuracy of the method was within 98-102% for all analytes. Conclusion: The developed analytical procedure meets the acceptance criteria of validation parameters and can be used in quality control laboratories for determination of benzydamine hydrochloride, methylparaben and peppermint oil in a spray dosage form.

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“…Considering all the above, the main aim of this work is to develop a rapid and simple analytical method for the simultaneous quantification of the five most common retinoids (Table 1) in cosmetic samples. The proposed method is based on LC-UV technique with a rapid treatment of the sample, by simple dilution with ethanol, a more benign solvent than those usually employed [21], and without requiring multistage sample preparation procedures. It provides similar or improved analytical features than the previous works with similar purpose, allowing to perform both pre-and in-market analytical control in the cosmetic sector.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Quantification of Vitamin A and Derivatives in Cosmetic Products by Liquid Chromatography with Ultraviolet Detection

et al. 2022

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Vitamin A (retinol) and some of its derivatives are a group of fat-soluble compounds used in cosmetic products as bioactive ingredients. Therefore, it is necessary to perform the quality control of final product to ensure their efficacy and safety. A simple and rapid method to determine retinol, retinal, retinyl acetate, retinyl propionate and retinyl palmitate in cosmetics is presented here. The method is based on vortex and/or ultrasound-assisted leaching of the analytes in ethanol followed by liquid chromatography with ultraviolet detection. The analytical performance of the method was evaluated. It has shown high levels of linearity, at least up to 100 µg mL−1; high precision with RSD values below 14% and high sensitivity with low MLODs ranging between 0.3 × 10−4 and 5.9 × 10−4 % w/w, which are enough to monitor these compounds in cosmetic products. The proposed method was successfully applied to seven commercial cosmetic samples to detect and quantify the target analytes, showing the method is suitable for its employment for quality control in cosmetic industries. Cosmetic samples were spiked at two levels of concentration and recovery values around 100% were obtained, showing no significant matrix effects and, therefore, external calibration was adequate for this determination.

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Green Analytical Chemistry, Opportunities for Pharmaceutical Quality Control

Cited by 8 publications

References 28 publications

Process modelling, design and technoeconomic Liquid–Liquid Extraction (LLE) optimisation for comparative evaluation of batch vs. continuous pharmaceutical manufacturing of atropine

Process modelling, design and technoeconomic Liquid–Liquid Extraction (LLE) optimisation for comparative evaluation of batch vs. continuous pharmaceutical manufacturing of atropine

Simultaneous Determination of Benzydamine Hydrochloride, Methylparaben and Peppermint Oil in a Spray Dosage Form by Gas Chromatography

Simultaneous Quantification of Vitamin A and Derivatives in Cosmetic Products by Liquid Chromatography with Ultraviolet Detection

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