The development of a robust and reliable analytical method is essential for ensuring the quality, safety, and efficacy of injectable drug products. For Investigational New Drug (IND) submission, regulatory agencies require validated analytical methods to assess product purity, potency, stability, and potential contaminants. This study aims to develop and validate analytical methods for a drug product (injection) to support IND submission, ensuring compliance with regulatory guidelines. Analytical techniques such as HPLC, was employed to identify and quantify impurities, degradation products, and for assay. The method validation was performed following ICH guidelines, assessing validation parameters. The validated analytical methods provide a reliable approach for quality control of injectable drug products, ensuring compliance with IND regulatory requirements. These methods will support further clinical development and regulatory approval processes.