Stability-indicating methods for the determination of erdosteine in the presence of its acid degradation products. 2014

Nadia M Moustafa, and Amr M Badawey, and Nesrine T Lamie, and Abd El-Aziz B Abd El-Aleem

Four accurate, sensitive, and reproducible stability-indicating methods for the determination of erdosteine in the presence of its acid degradation products are presented. The first method involves processing the spectra by using a first-derivative method at 229 nm in a concentration range of 10-70 microg/mL. The mean percentage recovery was 100.43 +/- 0.977. The second method is based on ratio-spectra first derivative spectrophotometry at 227.4 and 255 nm over a concentration range of 10-70 microg/mL. The mean percentage recovery was 99.65 +/- 1.122% and 100.02 +/- 1.306% at 227.4 and 255 nm, respectively. The third method utilizes quantitative densitometric evaluation of the TLC of erdosteine in the presence of its acid degradation products, and uses methanol-chloroform-ammonia (7 + 3 +/- 0.01, v/v/v) as the mobile phase. TLC chromatograms were scanned at 235 nm. This method analyzes erdosteine in a concentration range of 2.4-5.6 microg/spot, with a mean percentage recovery of 100.03 +/- 1.015%. The fourth method is HPLC for the simultaneous determination of erdosteine in the presence of its acid degradation products. The mobile phase consists of water-methanol (65 + 35, v/v). The standard curve of erdosteine showed good linearity over a concentration range of 10-80 microg/mL, with a mean percentage recovery of 99.90 +/- 1.207%. These methods were successfully applied to the determination of erdosteine in bulk powder, laboratory-prepared mixtures containing different percentages of the degradation products, and pharmaceutical dosage forms. The validity of results was assessed by applying the standard addition technique. The results obtained agreed statistically with those obtained by a reported method, showing no significant differences with respect to accuracy and precision.

UI MeSH Term Description Entries
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D002855 Chromatography, Thin Layer Chromatography on thin layers of adsorbents rather than in columns. The adsorbent can be alumina, silica gel, silicates, charcoals, or cellulose. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) Chromatography, Thin-Layer,Thin Layer Chromatography,Chromatographies, Thin Layer,Chromatographies, Thin-Layer,Thin Layer Chromatographies,Thin-Layer Chromatographies,Thin-Layer Chromatography
D003720 Densitometry The measurement of the density of a material by measuring the amount of light or radiation passing through (or absorbed by) the material. Densitometries
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D005100 Expectorants Agents that increase mucous excretion. Mucolytic agents, that is drugs that liquefy mucous secretions, are also included here. Expectorant,Mucolytic,Mucolytic Agent,Mucolytic Agents,Mucolytics,Agent, Mucolytic,Agents, Mucolytic
D006863 Hydrogen-Ion Concentration The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH pH,Concentration, Hydrogen-Ion,Concentrations, Hydrogen-Ion,Hydrogen Ion Concentration,Hydrogen-Ion Concentrations
D013055 Spectrophotometry, Infrared Spectrophotometry in the infrared region, usually for the purpose of chemical analysis through measurement of absorption spectra associated with rotational and vibrational energy levels of molecules. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) IR Spectra,Infrared Spectrophotometry,IR Spectras,Spectra, IR
D013058 Mass Spectrometry An analytical method used in determining the identity of a chemical based on its mass using mass analyzers/mass spectrometers. Mass Spectroscopy,Spectrometry, Mass,Spectroscopy, Mass,Spectrum Analysis, Mass,Analysis, Mass Spectrum,Mass Spectrum Analysis,Analyses, Mass Spectrum,Mass Spectrum Analyses,Spectrum Analyses, Mass
D013864 Thioglycolates Organic esters of thioglycolic acid (HS-CH2COOH). Thioglycollates
D013876 Thiophenes A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur. Thiophene

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