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Stability-indicating Method of Specnuezhenide in Bulk Drug and Its Kinetics and Mechanisms of Degradation in Aqueous Solutions

ISSN:2152-3924
2014年第Z1期

The stability of specnuezhenide( SPN) extracted from FRUCTUS LIGUSTRI LUCIDI( a commonly used official Chinese herbal)was investigated by using reversed-phase high-performance liquid chromatography( HPLC) and ultra-performance liquid chromatography/tandem mass spectrometry( UPLC/MS/MS) with a triple quadrupole( QQQ) mass detector( UPLC-MS-MS).SPN was subjected to forced decomposition under the alkaline,acidic,thermal,irradiation and oxidation conditions.The hydrolytic kinetics was calculated.Maximum stability of SPN was found at pH 7( t0.5= 288.81d).SPN was unstable in acidic,alkaline and irradiation conditions.The activation energy( Ea)of SPN degradation in aqueous solution at pH 7( most frequently applied condition) was 47.17kJ/mol.The results showed that the degradation of SPN was pH-,temperature- and irradiation-dependent and all followed first-order kinetics.Five degradation products were detected under those conditions,which were identified as salidroside,oleoside 11-methyl,oleoside dimethyl ester,nuezhenide and ligustroside.The possible hydrolytic pathway of SPN was proposed as epimerization reaction under irradiation,meanwhile hydrolysis and methylation in acidic,alkaline and thermal conditions.The stability-indicating method was established and validated by simultaneous determination of SPN and five degradation products in bulk drug.

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ISSN:2152-3924
2014年第Z1期

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