Determination of tromethamine in an eye-care pharmaceutical by capillary electrophoresis

Fa, McArdle; Cj, Meehan

doi:10.1039/a802417k

Cited by 9 publications

(5 citation statements)

References 16 publications

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“…CE with indirect UV-Vis absorption detection is useful for the determination of ionic analytes such as amines, metal ions, and organic acids [96][97][98][99][100][101][102][103][104][105][106][107][108]. However, we have learned that there are some limitations of indirect detection methods according to Eq.…”

Section: Scheme 1 Representative Derivatization Reactions Of Biogenimentioning

confidence: 99%

Analysis of biologically active amines by CE

et al. 2006

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This paper provides an overview on the current status of the analysis of biogenic amines by CE. The basic CE separation and detection strategies for the analysis of biogenic amines are briefly described. CZE and MEKC that provide highly efficient and reproducible analysis of biogenic amines are particularly surveyed. With respect to the detection of biogenic amines, we focus on LIF, UV-visible absorption, electrochemiluminescence, and MS. Derivatization strategies, indirect methods, and on-line concentration techniques such as field-amplified sample stacking, sweeping, and use of polymer solution are described. To show the practicality of CE, we highlight currently developed techniques for the determinations of biogenic amines in biological samples, including foods, beverages, cerebrospinal fluids, urine, and single cells.

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Section: Scheme 1 Representative Derivatization Reactions Of Biogenimentioning

confidence: 99%

Analysis of biologically active amines by CE

et al. 2006

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“…TRIS acts as an osmotic diuretic, increasing urine flow, urinary pH, and excretion of fixed acids, carbon dioxide and electrolytes [11]. Furthermore, TRIS is commonly used as an emulsifying agent in pharmaceutical and cosmetic products or as a counterion for acidic pharmaceutical compounds to generate desired salt forms [12][13][14][15][16]. Suitable quality control analytical methods are required to quantitate TRIS for regulatory purposes.…”

Section: Introductionmentioning

confidence: 99%

“…Naidong and Ghodbane determined TRIS as an excipient in Iopamidol injection (a formulated pharmaceutical product) by derivatization and LC-UV analysis at a concentration of 1.0 mg/mL [20]. Other methods include ion chromatography (IC) followed by conductivity detection [12] and a capillary electrophoresis (CE)-based method [14]. An alternative approach to realize sufficient retention of the polar TRIS compound is to use hydrophilic interaction chromatography (HILIC) as a normal phase prior to analysis with a refractive index (RI) detector [15].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of an Innovative Analytical Approach for the Quantitation of Tris(Hydroxymethyl)Aminomethane (TRIS) in Pharmaceutical Formulations by Liquid Chromatography Tandem Mass Spectrometry

et al. 2022

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A novel COVID-19 vaccine (BriLife®) has been developed by the Israel Institute for Biological Research (IIBR) to prevent the spread of the SARS-CoV-2 virus throughout the population in Israel. One of the components in the vaccine formulation is tris(hydroxymethyl)aminomethane (tromethamine, TRIS), a buffering agent. TRIS is a commonly used excipient in various approved parenteral medicinal products, including the mRNA COVID-19 vaccines produced by Pfizer/BioNtech and Moderna. TRIS is a hydrophilic basic compound that does not contain any chromophores/fluorophores and hence cannot be retained and detected by reverse-phase liquid chromatography (RPLC)-ultraviolet (UV)/fluorescence methods. Among the few extant methods for TRIS determination, all exhibit a lack of selectivity and/or sensitivity and require laborious sample treatment. In this study, LC–mass spectrometry (MS) with its inherent selectivity and sensitivity in the multiple reaction monitoring (MRM) mode was utilized, for the first time, as an alternative method for TRIS quantitation. Extensive validation of the developed method demonstrated suitable specificity, linearity, precision, accuracy and robustness over the investigated concentration range (1.2–4.8 mg/mL). Specifically, the R2 of the standard curve was >0.999, the recovery was >92%, and the coefficient of variance (%CV) was <12% and <6% for repeatability and intermediate precision, respectively. Moreover, the method was validated in accordance with strict Good Manufacturing Practice (GMP) guidelines. The developed method provides valuable tools that pharmaceutical companies can use for TRIS quantitation in vaccines and other pharmaceutical products.

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“…In this study, we formed multi-component caffeic acid crystals using tromethamine, which is a weakly basic amine compound, easily soluble in water [20], with a pKa of 8.07 [21]. Tromethamine has been shown to increase the dissolution rate of the active substance in several methods, including the formation of a binary system with sulfamethoxazole [22] and the formation of multi-component crystals with gliclazide [23], mefenamic acid [21], and glibenclamide [24].…”

Section: Introductionmentioning

confidence: 99%

The Formation and Characterization of Multicomponent Crystal Caffeic Acid-Tromethamine Using the Solvent Drop Grinding Technique

Jessica¹,

Amrizal²,

Hasanah³

et al. 2021

Advances in Health Sciences Research

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Caffeic acid is a polyphenol compound with low solubility in water. This study aims to prepare and characterize multicomponent crystals of caffeic acid, using tromethamine as a coformer, to enhance the dissolution rate without lessening its antioxidant effect. Multi-component crystals were prepared by the solvent-drop grinding method. The mole ratio of caffeic acid to tromethamine was 4:6 based on the results of a binary phase diagram showing that it had a eutectic point after which multi-component crystals were formed. Powder X-Ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC), FTIR spectroscopy, Scanning Electron Microscopy (SEM), and dissolution tests were used to characterize the multi-component crystals. The antioxidant effect was evaluated by the DPPH test. The characterization results revealed a decrease in intensity and new X-ray diffraction patterns, a lower melting point on the DSC thermogram, a non-significant wavenumber shift on the FTIR analysis, and a new crystal habit of multi-component crystals from the SEM. The dissolution rate of caffeic acid increased 1.23 times (p<0.05). The antioxidant test yielded 11.32 g/mL, 33.11 g/mL, and 28.35 g/mL compared with the IC50 values of gallic acid, caffeic acid, and multicomponent crystals. There was an increase in the antioxidant activity of caffeic acid in the form of multi-component crystals, but not significantly different from the IC50 of pure caffeic acid. Our findings show that after forming multicomponent crystals, the dissolution rate of caffeic acid increased without reducing antioxidant activity.

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Determination of tromethamine in an eye-care pharmaceutical by capillary electrophoresis

Cited by 9 publications

References 16 publications

Analysis of biologically active amines by CE

Analysis of biologically active amines by CE

Development and Validation of an Innovative Analytical Approach for the Quantitation of Tris(Hydroxymethyl)Aminomethane (TRIS) in Pharmaceutical Formulations by Liquid Chromatography Tandem Mass Spectrometry

The Formation and Characterization of Multicomponent Crystal Caffeic Acid-Tromethamine Using the Solvent Drop Grinding Technique

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