Determination of the Chemical Constituents and Spectral Properties of Commercial and NF Reference Standard Potassium Guaiacolsulfonate: Implications of the Findings on Compendial Analytical Methodology

Tangtatsawasdi, Paktiya; Krikorian, Sandrine

doi:10.1002/jps.2600730911

Cited by 3 publications

(5 citation statements)

References 6 publications

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“…Potassium guaiacolsulfonate was determined in bulk active compounds by UV-Vis spectrometry [5] and by HPLC in an C18 column in both bulk active compounds [6] and in pharmaceutical dosage forms [7, 8]. Sodium benzoate was analyzed by volumetric titration [4] and by HPLC in the C18 column [2, 3, 9] in bulk material and dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder

Phung

2019

Journal of Analytical Methods in Chemistry

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A novel HPLC method was developed and validated for simultaneous determination of potassium guaiacolsulfonate and sodium benzoate in pediatric oral powder. In this method, an analytical C8 column maintained at 25°C was used for chromatographic separation with a mixture of methanol and 0.02 M solution of tetrabutylammonium sulfate as the mobile phase. The composition of mobile phase was varied using a gradient program including an initial hold time of 7 minutes with methanol content maintained at 20% (v/v), followed by a linear gradient in 5.5 minutes in which methanol content was increased from 20% (v/v) to 50% (v/v) and a final hold time of 2.5 minutes with methanol content maintained at 20% (v/v). The total flow rate of mobile phase was maintained at 1.0 mL per minute. The UV detection was performed at 280 nm. Injection volume was set at 20 µl. The method was fully validated in terms of specificity, linearity, precision, accuracy, and robustness according to requirements of current guidelines and was proved as reliable and suitable for the intended application.

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Section: Introductionmentioning

confidence: 99%

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder

Phung

2019

Journal of Analytical Methods in Chemistry

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“…5 The synthesis has been known to yield two isomers: 4 potassium guaiacol-4-sulfonate and potassium guaiacol-5-sulfonate, ever since it was first reported, and it is not clear which of the two isomers is produced commercially. 3,5 According to Kawamura et al in 1987, commercially available PGS consists predominantly of potassium guaiacol-4-sulfonate. 2 They also established that the commercial form was a hydrate with at most 2/3 mol of water per mol of PGS.…”

Section: Introductionmentioning

confidence: 99%

“…Potassium guaiacolsulfonate (PGS) or potassium sulfoguaiacolate (Figure ) has been used for years as an expectorant to help loosen and clear mucus. , PGS has been derived from guaiacol, which was used prior to PGS. To reduce bad taste and irritation of the mucous membrane, guaiacol was sulfonated. , The salt potassium guaiacolsulfonate is still used in cough syrups and cold remedies . The synthesis has been known to yield two isomers: potassium guaiacol-4-sulfonate and potassium guaiacol-5-sulfonate, ever since it was first reported, and it is not clear which of the two isomers is produced commercially. , According to Kawamura et al in 1987, commercially available PGS consists predominantly of potassium guaiacol-4-sulfonate .…”

Section: Introductionmentioning

confidence: 99%

“…To reduce bad taste and irritation of the mucous membrane, guaiacol was sulfonated. , The salt potassium guaiacolsulfonate is still used in cough syrups and cold remedies . The synthesis has been known to yield two isomers: potassium guaiacol-4-sulfonate and potassium guaiacol-5-sulfonate, ever since it was first reported, and it is not clear which of the two isomers is produced commercially. , According to Kawamura et al in 1987, commercially available PGS consists predominantly of potassium guaiacol-4-sulfonate . They also established that the commercial form was a hydrate with at most 2/3 mol of water per mol of PGS .…”

Section: Introductionmentioning

confidence: 99%

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Solid-State Properties and Dehydration Behavior of the Active Pharmaceutical Ingredient Potassium Guaiacol-4-sulfonate

Mahé¹,

Nicolaı̈²,

Perrin³

et al. 2013

Crystal Growth & Design

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Potassium guaiacolsulfonate is an active pharmaceutical ingredient that has been in use for more than a century, and it is still widely used in cough syrups. Nonetheless, no crystal structure has ever been determined to facilitate quality control. This is all the more surprising because two isomers are known to exist. A commercial sample has been studied by X-ray diffraction and thermogravimetric methods. It consists of potassium guaiacol-4-sulfonate, and it crystallizes in the monoclinic space group C2/c as a hemihydrate. The crystals exhibit uniaxial negative thermal expansion, and the electrostatic forces between the ions appear to be the major driving force of the observed displacements. Dehydration of the hemihydrate was observed above 380 K. The anhydrate has a structure similar to the hemihydrate with almost the same unit cell parameters. The dehydration kinetics points to a displacive mechanism; water molecules are located in channels, through which they leave the crystal. The structural readjustments that occur to accommodate the loss of water are driven by electrostatic interactions between the ions similar to the displacements observed for thermal expansion. Under ambient conditions (and humidity), the anhydrate is not stable and transforms into the hemihydrate.

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“…The enantiomers of ibuprofen, benoxaprofen, fenoprofen, and naproxen were separated on a silica column modified with (R)-N-(3,5-dinitrobenzoyl)phenylglycine (236D). Similarly HPLC has been used to analyze a number of pharmaceuticals used in cough-cold products (46D,79D,86D,HOD,116D,126D,132D,150D,167D,179D,193D,203D,221D,237D,240D,242D). In the case of phenoxypropanolamines, the influence of additives in the mobile phase was studied (178D).…”

Section: Nitrogen-and Oxygen-containing Compoundsmentioning

confidence: 99%

Pharmaceuticals and related drugs

Gilpin¹,

Pachla²

1987

Anal. Chem.

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Determination of the Chemical Constituents and Spectral Properties of Commercial and NF Reference Standard Potassium Guaiacolsulfonate: Implications of the Findings on Compendial Analytical Methodology

Cited by 3 publications

References 6 publications

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder

Solid-State Properties and Dehydration Behavior of the Active Pharmaceutical Ingredient Potassium Guaiacol-4-sulfonate

Pharmaceuticals and related drugs

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