Thursday , 29 February 2024

Development and Validation of Stability Indicating RP-HPLC Method for Amoxicillin and Clavulanate Potassium Related Impurities in Pharmaceutical Dosage Forms

Konda Sidda Reddy*1, Ramamohana Reddy Maddike2, J Sreeramulu2
1Department of Chemistry, Rayalaseema University, Kurnool, Andhra Pradesh, India.
2Departments of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India.

A simple, cost effective, stability indicating reversed-phase High Performance Liquid Chromatography method was developed for separation and quantification of seventeen specified known related impurities in Amoxicillin and Clavulanate Potassium pharmaceutical dosage form using simple gradient method. The chromatographic conditions comprised a reversed-phase Agilent eclipsed C18 column and UV detection at 210 nm with 1.0 mL / min flow rate at 45 ºC column oven temperature. In gradient mobile phase composition-A contains 0.05 M potassium dihydrogen phosphate buffer of pH 3.4 and Composition-B contains mixture of Acetonitrile and 0.05 M potassium dihydrogen phosphate of pH 4.2 in 80:20. The method validation data showed excellent results for Precision, Linearity, Specificity, Accuracy, Limit of detection, Limit of Quantification and robustness.

Keywords: Amoxicillin, Clavulanate Potassium, Method development, Validation, Related impurities.

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