Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Amoxicillin Formulations

International Journal of Chemistry | Vol. 8, No. 9, September 2017 | pp. 65–72

DOI: 10.46882/2017/IJC/000108

Article Type: Original Research Paper

Title: Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Amoxicillin Formulations

Names of Authors: E. O. Effiong¹, L. A. S. dos Santos²*

Authors’ Affiliations:
¹Department of Chemistry, University of Uyo, Uyo, Nigeria.
²Department of Pharmacy, Federal University of Minas Gerais, Belo Horizonte, Brazil.

Abstract: Developing simple, automated, and accurate analytical methods is essential for routine quality monitoring and the detection of counterfeit beta-lactam antibiotics in commercial pharmacies. This paper describes the development and validation of a rapid Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative determination of amoxicillin in capsule dosage forms. Separation was achieved using a C18 stationary phase column under an isocratic mobile phase composed of phosphate buffer (pH 4.0)-acetonitrile (85:15 v/v), at a flow rate of 1.0 mL/min. Eluent monitoring was executed spectrophotometrically at a wavelength maximum of 230 nm. Method validation parameters followed the International Council for Harmonisation (ICH) guidelines. Excellent linearity was established over a concentration range of 2.0 to 50.0 mg/L with a correlation coefficient (R²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.06 mg/L and 0.18 mg/L, respectively. Precision assessments yielded relative standard deviations (RSD) below 1.4%. The validated method was successfully applied to screen six commercial amoxicillin brands, producing recovery percentages between 98.6% and 101.4% with no interference from common excipients.

Keywords: RP-HPLC; Amoxicillin; Quantitative analysis; Method validation; Pharmaceuticals; Quality control

Manuscript Timeline: Received: September 02, 2016; Revised: October 12, 2016; Accepted: November 05, 2016; Published: September 09, 2017.

Citation: Effiong, E. O., & dos Santos, L. A. S. (2017). Development and Validation of an RP-HPLC Method for Quantitative Monitoring of Amoxicillin Formulations. International Journal of Chemistry, 8(9), 65–72.

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