Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Amoxicillin and Clavulanic Acid in Injection

Abstract

A simple, fast, precise, accurate and rugged stability indicating high performance liquid chromatography (HPLC) method has been developed for simultaneous estimation of Amoxicillin and Clavulanic acid from injectable dosage form. The stability indicating capability of the method was proven by subjecting the drugs to stress conditions as per ICH recommended test conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation and resolution of the degradation products formed therein. The separation was obtained using a mobile phase composition at a ratio of 95:5 (v/v) of pH 5.0 buffer and methanol on Inertsil C18 column (250 × 4.0 mm, 4 μm) with UV detection at 220 nm at a flow rate of 1 ml/minute. The photodiode array detector was used for stress studies. The order of elution of peaks was Clavulanic acid followed by Amoxicillin. The linear calibration range was found to be 79.51 to 315.32 μg/ml for Amoxicillin and 17.82 to 67.90 μg/ml for Clavulanic acid. The Amoxicillin and Clavulanic acid were found to be stable in solution up to 24 hours. The method validation data showed excellent results for precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.

Fluorescence‐based sensor for selective and sensitive detection of amoxicillin (Amox) in aqueous medium: Application to pharmaceutical and biomedical analysis

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A Natural Deep Eutectic Solvent Formulated to Stabilize β-Lactam Antibiotics

“…High Performance Liquid Chromatography (HPLC) analysis was performed, for each molecule under study, based on previous reported methods 24 , 25 . CLV and IMP were measured using a VWR Hitachi LaChromElite equipped with column oven, auto sampler, and UV-DAD detector.…”

Development and Validation of HPLC Method for Simultaneous Estimation of Amoxycillin Trihydrate and Potassium Clavulanate in Pure and Marketed Tablet Dosage Form

“…The analysis was carried out on HPLC system using the column Inertsil C18 (5µm, 250×4.6mm); with UV detection of 249 nm, column temperature was maintained upto 37 0 C. The injection volume used was 20µl with a flow rate of 1.0ml/min. [6,7]…”