Development and Validation of RP-HPLC Method for Estimation of Impurities of Cefprozil in its Powder for Oral Suspension Dosage form Using Sub 2-μm Column

A reversed-phase high-performance liquid chromatographic method for separation and quantification of impurities of Cefprozil powder for oral suspension dosage form has been developed and validated. Chromatography was performed on a 100 x 4.6 mm, 1.8-μm particle, C18 column with mobile phase-A, 0.23% Ammonium dihydrogen orthophosphate in water and mobile phase-B, 80: 20 (v/v) Methanol – mobile phase-A by gradient elution. The system was operated at 0.6 mL min⁻¹ mobile phase flow rate and the column thermostat was maintained at 25°C. UV detection was performed at 290 nm. Forced degradation studies were conducted on Drug product using ICH stress study guidelines to demonstrate the specificity and stability-indicating nature of the method. The method was validated for precision, accuracy, linearity, specificity and sensitivity in accordance with ICH guidelines. LOD and LOQ for individual impurities were below 0.014 and 0.037% (w/w) respectively. Validation revealed the method is specific, precise, accurate, linear, robust and reproducible.