Reliable assay of extreme enantiomeric purity values by a new circular dichroism based HPLC detection system.
A new sensitive, selective, and versatile circular dichroism (CD)-based HPLC detection system was used for the validation of the enantiomeric purity assay in the quality control of chiral drugs upon nonchiral stationary phases. The precision and the accuracy of the method were checked for selected samples showing values of the anisotropy factor on the order of 10(-1) to 10(-4). Very high accuracy has been obtained also in the case of extreme enantiomeric purity values (</=1% or >/=99% e.p.) and of a low anisotropy factor (g = 2 x 10(-4)) compound. The high selectivity of this detection system allows a selective monitoring of analytes in complex mixtures and makes the baseline stable.
Bertucci
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C.N.R., C.M.S.O.A., Dipartimento di Chimica e Chimica Industriale, Università di Pisa, Pisa, Italy.
Andrisano
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Cavrini
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Castiglioni
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E
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002942:Circular Dichroism; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013237:Stereoisomerism