A Validated RP-HPLC Method Development for Amoxicillin in Pharmaceutical Dosage Forms

Sivagami B, Sharmil Kumar L.M, Bhaskar M, Kareem Aktar, Nagendra Babu G, Krishna Ekanth C, Niranjan Babu M.

Abstract


A rapid and simple Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the quantification of Amoxicillin in tablet dosage form. Separation was achieved on Chromatopak-C18 (250mm×4.6×5micron) column in isocratic mode with mobile phase consisting of Acetonitrile: 0.2M Potassium dihydrogen phosphate buffer (pH 3) (22:78v/v) and conditions optimized with flow rate of 1 ml/minute and wavelength of detection at 283 nm. The retention time of Amoxicillin was found to be 6.4 min. Linearity was established for Amoxicillin in the range 10 – 100 μg / ml with R2 value 0.999. This method was validated in accordance with ICH guidelines, the linearity, accuracy, precision, specificity, robustness, ruggedness, and system suitability results were within the acceptance criteria. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of Amoxicillin for Quality Control level.

 


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DOI: https://doi.org/10.7439/ijapa.v8i1.4727

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