RP-HPLC Method Development and Validation of Determination of Cefadroxil and Potassium Clavulanate Tablets

Abstract

Cefadroxil (CEF) and Potassium Clavulanate (CLV) are used in combination as an antibacterial tablet formulation for the treatment of various bacterial infections including respiratory tract, skin, and urinary tract infections. A simple, sensitive, rapid, precise and accurate reverse phase high-performance liquid chromatographic (RP-HPLC) method has beendeveloped and validated for the simultaneous determination of Cefadroxil and Potassium Clavulanate in combined tablet dosage form. Chromatographic separation was achieved on an Agilent C18 (250 × 4.6 mm, 5 µm) column using a mobile phase consisting of Potassium dihydrogen phosphate buffer: Acetonitrile: Methanol in the ratio of 20:70:10 v/v adjusted to pH 5.0 with Orthophosphoric acid, at a flow rate of 1.0 mL/min. UV detection was performed at 225 nm with an injection volume of 20 µL. The retention time for Potassium Clavulanate and Cefadroxil was found to be

1.98 min and 6.08 min respectively. The method was validated as per ICH Q2(R1) guidelines for parameters including system suitability, specificity, linearity, precision, accuracy, ruggedness, and robustness. The linearity was established in the concentration range of 25–125 µg/mL for Clavulanate and 100–500 µg/mL for Cefadroxil with a correlation coefficient (r²) of 0.999 for both drugs. The developed method is simple, economical, and reproducible and can be employed for routine quality control analysis of the combined tablet formulation.

Keywords: Cefadroxil, Potassium Clavulanate, RP-HPLC, ICH validation, Simultaneous estimation, Pharmaceutical formulation