Ion chromatographic method for rapid and quantitative determination of tromethamine

Hall, Rex E.; Havner, Grey D.; Good, R C; Dunn, Danny L.

doi:10.1016/0021-9673(95)00699-0

Cited by 10 publications

(5 citation statements)

References 5 publications

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“…Not unexpectedly CE offers the lowest precision, while the IC methodology is more robust but requires frequent column regeneration due to reported loss in efficiency [38]. Application of HILIC with refractive index (RI) detection offers good performance [36,39], but is restricted to isocratic separations as RI is not compatible with gradient elution.…”

Section: Hydrophilic Interaction and Mixed-mode Liquid Chromatographymentioning

confidence: 99%

“…In Table 1, methodologies for the determination of TRIS in pharmaceutical salts [38,39] are briefly described and their results compared. Not unexpectedly CE offers the lowest precision, while the IC methodology is more robust but requires frequent column regeneration due to reported loss in efficiency [38].…”

Section: Hydrophilic Interaction and Mixed-mode Liquid Chromatographymentioning

confidence: 99%

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Analytical Methods for Determination of Counter-ions in Pharmaceutical Salts

Rocheleau¹

2008

CPA

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Inorganic ions as well as organic acids or bases are frequently employed as counter-ions of ionizable drug substances. Therefore, analytical methods are required to confirm production of the correct salt form and to quantify the level of the counter-ion present in each batch of drug substances manufactured. Several options exist for determination of counter-ions in pharmaceutical salts and will be discussed in this review. Ion chromatography (IC) with conductivity detection is probably the most frequently employed method for ion determination. Other techniques such as capillary electrophoresis (CE) represent an alternative to IC for determination of counter-ions in pharmaceutical salts. Due to the lack of chromophores, detection of small ions in CE is typically performed using indirect UV detection. Hydrophilic interaction chromatography (HILIC) with evaporative light-scattering (ELSD) or refractive index detection can also be used for determination of non-UV absorbing ions. Each technique will be described and their advantages highlighted. Current and future trends in measuring counter-ions in pharmaceutical salts will also be discussed.

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Section: Hydrophilic Interaction and Mixed-mode Liquid Chromatographymentioning

confidence: 99%

Section: Hydrophilic Interaction and Mixed-mode Liquid Chromatographymentioning

confidence: 99%

Analytical Methods for Determination of Counter-ions in Pharmaceutical Salts

Rocheleau¹

2008

CPA

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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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“…Tromethamine has been determined by high-performance liquid chromatography (HPLC) with fluorescence 16 and UV 17 detection with retention times of 12 and 15 min, respectively. It has also been determined by ion chromatography (IC) with conductivity detection 18 and by gas chromatography (GC) with flame ionisation detection 19 with retention times of 5.4 and 3.6 min, respectively. For fluorescence, UV and flame ionisation detection, derivatisation of tromethamine is required, which leads to lengthy sample preparation times.…”

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confidence: 99%

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

Cj²

1998

Analyst

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Tromethamine [tris(hydroxymethyl)aminomethane] is used as an emulsifying agent, alkaliser and buffering agent in pharmaceutical preparations such as eye-care solutions. A new method for the determination of this compound in an eye-care preparation was developed using capillary zone electrophoresis with indirect UV detection. The method displayed linearity between 2.5 and 25 mg l-1 with a correlation coefficient of 0.9992. The limit of detection was 2.5 mg l-1. Precision and accuracy were determined as relative standard deviation and % deviation, and were found to be 0.42% and 1.62%, respectively. Recovery studies of tromethamine in the pharmaceutical preparation gave a 102.98% recovery.

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Ion chromatographic method for rapid and quantitative determination of tromethamine

Cited by 10 publications

References 5 publications

Analytical Methods for Determination of Counter-ions in Pharmaceutical Salts

Analytical Methods for Determination of Counter-ions in Pharmaceutical Salts

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

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

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