Stability indicating method for famotidine in pharmaceuticals using porous graphitic carbon column.
A simple, sensitive and rapid HPLC method was developed and validated for the simultaneous determination of famotidine (FMT) and related impurities in pharmaceuticals. Chromatographic separation was accomplished within 10 min on a porous graphitic carbon (PGC) column using 50:50 v/v ACN-water containing 0.5% pentane sulphonic acid (PSA) as the mobile phase. Separation was achieved with a flow rate of 1 mL/min and a detection wavelength of 265 nm. The calibration curves were linear over a concentration range of 1.5-100 microg/mL. The intra- and interday RSDs (n = 5) for the retention times and peak area were all less than 2%. The method was sensitive with an LOD (S/N = 3) of 0.1 microg/mL for FMT, imp. C and 0.05 microg/mL for imp. 2, A and D. All recoveries were greater than 98%. The method was demonstrated to be precise, accurate and specific with no interference from the tablet ingredients and separation of the drug peak from the peaks of the degradation products (oxidative degradation and acid and base degradation). The results indicated that the proposed method could be used for the determination of FMT in commercial dosage forms and as a stability-indicating assay.
Helali
Nawel
N
Institut National des Sciences Appliquées et de Technologie, Centre Urbain Nord, Tunis Cedex, Tunisia.
Monser
Lotfi
L
D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation; D004355:Drug Stability; D015738:Famotidine / Q000737:chemistry*; D006108:Graphite / Q000737:chemistry*; D006635:Histamine H2 Antagonists / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D006635:Histamine H2 Antagonists; D004364:Pharmaceutical Preparations; D015738:Famotidine; D006108:Graphite