Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase

• Authors: Paraskevas Tzanavaras
• Languages of publication: EN

Abstracts

EN

An HPLC method for the quality control of famotidine (FMT) containing formulations has been developed and validated. The combination of a short monolithic column (Chromolith® RP-18e 50 × 4.6 mm i.d.) and an elevated flow rate (3.0 mL min−1) enabled the proposal of a high-throughput analytical scheme capable of reliable operation in a demanding industrial environment. Detection was carried out at 265 nm. Thorough validation of the method included linearity (5–150%), limits of detection (0.13%) and quantification (0.41%), selectivity, precision (within- and day-to-day), accuracy and ruggedness. The new method was applied successfully to the analysis of samples (assay, dissolution, dosage & blending uniformity) during the production of four validation batches of FMT-containing tablets.

Keywords

EN

Famotidine; High Performance Liquid Chromatography; Monolithic column; Quality Control; Pharmaceutical formulations

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2011
• Volume: 9
• Issue: 3
• Pages: 446-452

Dates

published

1 - 6 - 2011

online

22 - 3 - 2011

Contributors

author

Paraskevas Tzanavaras

• Aristotle University of Thessaloniki

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Identifiers

DOI

10.2478/s11532-011-0022-x