Assay analysis of Amoxicillin and Clavulanate Potassium as per USP

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Amoxicillin and Clavulanate Assay as per USP. The analysis was performed on a Thermo Scientific Syncronis aQ L1 HPLC column using the method described in the USP 40 monograph. The results obtained were found to be within acceptance criteria as stated in the USP. Resolution between Amoxicillin and clavulanic acid was 14.0 (USP criteria: not less than 3.5). Tailing Factors observed were 0.84 & 1.25 respectively (USP criteria: not more than 1.5 for each analyte). RSD found to be less than 2% for both analytes

AN262: Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate

Instrument Type: IC

Clavulanic acid is a potent beta-lactamase inhibitor. 2-ethylhexanoic acid is a potential impurity. This work presents a simpler IC method using a Reagent-Free Ion Chromatography (RFIC) system with suppressed conductivity detection and IonPac AS11 column for the detection and quantification of 2-ethylhexanoic acid. Results for LOD/LOQ, linear calibration range, spike recovery, retention time precision, and peak area precision determinations show that IC is an accurate and reproducible technique to determine 2-ethylhexanoic acid in clavulanate below the 0.8% acceptance criteria.