Impurity profiling of Famotidine in bulk drugs and pharmaceutical formulations by RP-HPLC method using ion pairing agent
By M.Vamsi Krishna, G. Madhavi, L. A. Rama Prasad and D. Gowri Sankar
An efficient reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for quantitation of famotidine and its process impurities which may coexist in bulk drugs and in solid pharmaceutical dosage forms. The separation was achieved on a C18 column (250 mm x 4.6 mm) using a mobile phase of acetonitrile, methanol and 1-Hexane sodium sulfonate. Flow rate was 1.5 ml/min. The photo diode array detector was operated at 266 nm. The method was validated for specificity, linearity, precision, accuracy and limit of quantification. The degree of linearity of the calibration curves, the percent recoveries of famotidine and impurities, the limit of detection and quantitation, for the HPLC method were determined. The method was found to be simple, specific, precise, accurate and reproducible. The method was applied for the quality control of commercial famotidine tablets to quantify the drug and its related substances and to check the formulation content uniformity.
Key Words : Famotidine; Impurity profiling; Ion pairing agent; Reversed-phase HPLC.
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