Development and validation of a fully automated method for the chromatographic determination of content uniformity of drug tablets.
A fully automated method for the content uniformity analysis of LAS 34475 25mg tablets has been developed by using an automated procedure. This automated method has been validated within the requirements of ICH guidelines Q2A-Q2B. Standard and sample solutions are processed by an automated benchtop system. The operations automated include the phases of disintegration of the dosage form, filtration of the resultant homogenate and injection of the clear sample into the chromatographic system. Although a manual method validated according to ICH guidelines already existed for this compound, the benefits of applying appropriate automation should provide continuous operation, increased precision, an affordable electronic audit trail and significantly reduced time consumption as well as reducing the exposure of the analyst to the drug substance. The objective of this work was to adapt the manual method to an automated workstation. Considerable effort went into developing and validating an automated method. The results obtained in the validation of this automated method were equivalent to the manual method in terms of system precision, linearity, accuracy, robustness and sensitivity (limits of detection, LOD and limits of quantification, LOQ), and carry-over.
Toro
I
I
Almirall Prodesfarma S.A., Analysis R&D Department, C/Cardener 68-74, E-08024 Barcelona, Spain. itoro@almirallprodesfarma.com
Dulsat
J F
JF
Fábregas
J L
JL
Claramunt
J
J
D001331:Automation; D002851:Chromatography, High Pressure Liquid; D015507:Drugs, Investigational / Q000032:analysis* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets / Q000032:analysis / Q000592:standards; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods / Q000592:standards
D015507:Drugs, Investigational; D013607:Tablets