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  1. 1 Open Chemistry

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  1. 1 2011

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  1. 1 Tzanavaras P.

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

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Tzanavaras P.
Open Chemistry
|
2011
|
vol. 9
|
issue 3
446-452
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.
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