Stress Degradation studies on Faropenem Sodium and Development of a Validated method by UV. Spectrophotometer in bulk and pharmaceutical dosage form

To develop and validate a simple, precise, accurate and stability indicating UV method for estimation of faropenem sodium. UV, HPLC and many more experiment were carried out by taking single drug and also by combining with other drug. However, such type of studies was not reported. In the developed methods for analysis and stress degradation,  faropenem sodium was found to have the absorbance maxima at 300nm. Method A involved method development and validation and method B involved forced degradation study. In these methods methanol was used as a solvent. Linearity was observed in the concentration range of 10-50µg/ml. validation experiments were performed to demonstrate system suitability, specificity, precision, linearity, accuracy, robustness, LOD and LOQ as per International Conference on Harmonization guidelines. Furthermore, stability studies of faropenem sodium were carried out under acidic, alkali, oxidation and thermal degradation as per stability indicating assay methods. The result of analysis have been validated and recovery studies were carried out using a standard addition method by adding specific amount(80%,100% and 120%) and show recovery studies in range(99.34-101.24)%. The proposed method can be successfully applied for method development, validation and stability study of faropenem sodium.