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.
Financed by the National Centre for Research and Development under grant No. SP/I/1/77065/10 by the strategic scientific research and experimental development program:
SYNAT - “Interdisciplinary System for Interactive Scientific and Scientific-Technical Information”.