Development and Validation of a Gas Chromatographic Method for Quantitative Determination of the Active Ingredient in Phenyl Salicylate Drug Substance

Anew method for quantitative determination of the active ingredient in phenyl salicylate drug substance using gas chromatography with flame-ionization detection (GC-FID) was developed and validated. The experiments used an HP-5 quartz capillary column with a grafted stationary phase of diphenyl- (5%...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2020-04, Vol.54 (1), p.73-78
Main Authors: Kupriyanova, O. V., Milyukov, V. A., Shevyrin, V. A., Sadykova, R. G., Mustafin, R. I.
Format: Article
Language:English
Subjects:
Analysis
Chromatography
Medicine
Methods
Methyl salicylate
Nonsteroidal anti-inflammatory drugs
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Substance abuse
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Summary:Anew method for quantitative determination of the active ingredient in phenyl salicylate drug substance using gas chromatography with flame-ionization detection (GC-FID) was developed and validated. The experiments used an HP-5 quartz capillary column with a grafted stationary phase of diphenyl- (5%) and dimethylpolysiloxane (95%) (Agilent Technologies, USA). The conditions for the chromatographic separation and the chromatography system suitability parameters were determined. The phenyl salicylate content in the drug substance was determined by the internal standard method. The method was validated for specificity, linearity, precision, and stability (robustness) and was found to meet the main acceptance criteria.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-020-02159-1