METHODS AND OBJECTS OF CHEMICAL ANALYSIS
ISSN title: "Metody i obʺekty himičeskogo analiza"
An international journal devoted to all aspects of Analytical chemistry
ISSN 2413-6166 (Online), ISSN 1991-0290 (Print)
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METHODS AND OBJECTS OF CHEMICAL ANALYSIS ISSN title: "Metody i obʺekty himičeskogo analiza" An international journal devoted to all aspects of Analytical chemistry ISSN 2413-6166 (Online), ISSN 1991-0290 (Print) |
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DEVELOPMENT AND VALIDATION 4-AMINOBUTYRIC ACID ASSAY IN ALENDRONATE SODIUM TABLETS USING MICELLAR THIN-LAYER CHROMATOG-RAPHY
The assay method for the determination of 4-aminobutyric acid as impurity in Alendronate so-dium tablets by using micellar thin-layer chromatography was developed. Micellar mobile phase (0.005 mol/l Brij-35 aqueous solution adjusted to pH 2.0 HCl) allow to separate 4-aminobutyric acid both active component and pharmaceutical excipients, and to assay this impurity during 20 min. For the develop-ment method the validation procedure was done: linearity was 0.012-0.028 mg/ml; limit of detection was 0.002 mg/ml (0.1 mcg/spot); limit of quantitation was 0.006 mg/ml (0.3 mcg/spot); relative standard de-viations that were obtained during precision, accuracy and reproducibility investigations not exceed 5%.
Key words: 4-aminobutyric acid, micellar thin-layer chromatography, Brij-35, assay, validation
Publisher:Taras Shevchenko National University, Kiev Ukraine
(Analytical chemistry department at Taras Shevchenko
National University, 64 Vladimirskaya STR., Kiev, 01601 UKRAINE)
analysis@univ.kiev.ua,
www.univ.kiev.ua,
+380-44-2393266
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The journal website: www.moca.net.ua
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CC BY 4.0
