Abstract

DEVELOPMENT AND VALIDATION OF A GREEN RP-HPLC METHOD FOR QUANTIFICATION OF CEFADROXIL CAPSULES

Bianca Aparecida De Marco* and Hérida Regina Nunes Salgado

ABSTRACT

A new and efficient method was developed and validated for the identification and quantification of the cefadroxil monohydrate capsules by RP-HPLC, aiming the contribution to the green chemistry since it has low use of organic solvent and low production of toxic waste. The RP-HPLC method was performed in isocratic mode with temperature at 25°C. The mobile phase consisted of ethanol + acidified water with orthophosphoric acid 0.1% (8:92 v/v), on column Zorbax-SB C18 (150 mm x 4.6 mm, 5 μm) at a flow rate of 0.8 mL min-1 with 10 μL of injected volumes, with UV/DAD detection at 230 nm. The method was linear over the concentration range of 20–120 μg/mL with (r = 0.9999) and retention time (RT) equal to 6.1 minutes. Statistical analysis provided reliable, safety and reproducible results. The method did not use buffering solutions, presented good analysis time and practicality in the execution making economic for the industry. The method is considered adequate and safe to be used in routine quality control analyzes for determination and quantification of cefadroxil monohydrate capsules.

Keywords: Cefadroxil, green analytical method, quality control, RP-HPLC, validation.