Identification, isolation, and characterization of unknown degradation products of cefprozil monohydrate by high-performance thin-layer chromatography

Abstract

The present research work was aimed to determine the stability of cefprozil monohydrate (CEFZ) as per various stress degradation conditions recommended by International Conference on Harmonization (ICH) guideline Q1A (R2). Forced degradation studies were carried out for hydrolytic, oxidative, photolytic, and thermal stress conditions. The drug was found susceptible for degradation under all stress conditions. Separation was carried out by using high-performance thin-layer chromatographic system (HPTLC). Aluminum plates precoated with silica gel 60 F254 were used as the stationary phase. The mobile phase consisted of ethyl acetate-acetone-methanol-water-glacial acetic acid (7.5:2.5:2.5:1.5:0.5 v/v). Densitometric analysis was carried out at 280 nm. The system was found to give compact spot for cefprozil monohydrate (0.45 RF). The method was validated for precision, accuracy, specificity, and robustness. The linear regression analysis data showed good linear relationship in the concentration range of 200–50...