A validated HPLC stability-indicating method for the determination of diacerhein in bulk drug substance

A novel stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the assay of diacerhein in bulk forms. Diacerhein was found to degrade in alkaline and acidic conditions and also under oxidative stress. The drug was stable to dry heat and in presence...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2005-09, Vol.39 (3), p.776-780
Hauptverfasser:	Giannellini, Valerio, Salvatore, Francesco, Bartolucci, Gianluca, Coran, Silvia A., Bambagiotti-Alberti, Massimo
Format:	Artikel
Sprache:	eng
Schlagworte:	Aloe-emodin Analysis Analytical, structural and metabolic biochemistry Anthraquinones - analysis Anthraquinones - chemistry Anti-Inflammatory Agents, Non-Steroidal - analysis Anti-Inflammatory Agents, Non-Steroidal - chemistry Biological and medical sciences Calibration Chemistry, Pharmaceutical - methods Chromatography Chromatography, High Pressure Liquid - methods Diacerhein Drug Contamination Drug Stability Fundamental and applied biological sciences. Psychology General pharmacology HPLC Hydrogen-Ion Concentration Mass Spectrometry Medical sciences Methanol - pharmacology Models, Chemical Oxidative Stress Pharmaceutical Preparations - analysis Pharmacology. Drug treatments Phosphoric Acids - pharmacology Quality Control Rhein Sensitivity and Specificity Spectrophotometry, Ultraviolet Stability-indicating Technology, Pharmaceutical - methods Time Factors
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Zusammenfassung:	A novel stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the assay of diacerhein in bulk forms. Diacerhein was found to degrade in alkaline and acidic conditions and also under oxidative stress. The drug was stable to dry heat and in presence of light. Resolution of drug, its potential impurities and degradation products were achieved on a RP18 (endcapped) column utilizing 0.1 M phosphoric acid and methanol (40:60, v/v) as eluent at the detection wavelength of 254 nm. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intermediate precision), accurate and robust.
ISSN:	0731-7085 1873-264X
DOI:	10.1016/j.jpba.2005.04.040