6533b7dbfe1ef96bd1270299
RESEARCH PRODUCT
Chromatographic multivariate quality control of pharmaceuticals giving strongly overlapped peaks based on the chromatogram profile
D Ruiz-rochLaura Escuder-gilabertRosa María Villanueva-camañasSalvador SagradoM.j. Medina-hernándezsubject
Quality ControlProtocol (science)Multivariate statisticsAnalyteChromatographyChemistryOrganic ChemistryGeneral MedicineReference StandardsPharmaceutical formulationBiochemistryAnalytical ChemistryChemometricsQuality (physics)Pharmaceutical PreparationsApproximation errorMultivariate AnalysisPartial least squares regressiondescription
In the present paper, the simultaneous quantification of two analytes showing strongly overlapped chromatographic peaks (alpha = 1.02), under the assumption that both available equipment and training of the laboratory staff are basic, is studied. A pharmaceutical preparation (Mutabase) containing two drugs of similar physicochemical properties (amitriptyline and perphenazine) is selected as case of study. The assays are carried out under realistic working conditions (i.e. routine testing laboratories). Uncertainty considerations are introduced in the study. A partial least squares model is directly applied to the chromatographic data (with no previous signal transformation) to perform quality control of the pharmaceutical formulation. Under the adequate protocol, the relative error in prediction of analytes is within the tolerances found in the pharmacopeia (10%). For spiked samples simulating formulation mistakes, the errors found have the same magnitude and sign to those provoked.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2004-03-23 | Journal of Chromatography A |