Validation of an RP-HPLC Method for Quantitative Monitoring of Azithromycin Formulations

International Journal of Chemistry | Vol. 13, No. 9, September 2022 | pp. 65–72

DOI: 10.46882/2022/IJC/000167

Article Type: Original Research Paper

Title: Validation of an RP-HPLC Method for Quantitative Monitoring of Azithromycin 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 macrolide 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 azithromycin in tablet dosage forms. Separation was achieved using a C18 stationary phase column under an isocratic mobile phase composed of acetonitrile-methanol-phosphate buffer (pH 6.5) (45:35:20 v/v/v), at a flow rate of 1.0 mL/min. Eluent monitoring was executed spectrophotometrically at a wavelength maximum of 215 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 brands, producing recovery percentages between 98.6% and 101.4% with no interference from common excipients.

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

Manuscript Timeline: Received: September 02, 2021; Revised: October 12, 2021; Accepted: November 05, 2021; Published: September 09, 2022.

Citation: Effiong, E. O., & dos Santos, L. A. S. (2022). Validation of an RP-HPLC Method for Quantitative Monitoring of Azithromycin Formulations. International Journal of Chemistry, 13(9), 65–72.

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