A novel HPLC method for analysis of atosiban and its five related substances in atosiban acetate injection.

This study focuses on a novel hplc method for analysis of atosiban and its five related substances in atosiban acetate injection.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the pharmaceutical field. Consulting the national pharmacopoeia, no official quality standard was found for estimation of related substances and assay of atosiban acetate injection, of which main active component is atosiban. To solve this problem, herein, a novel high performance liquid chromatographic (HPLC) method was developed and validated in this study. A chromatographic... Research Background and Significance Atosiban acetate injection is widely used in clinical settings as a tocolytic agent to inhibit premature labor. The primary active pharmaceutical ingredient (API) is atosiban, a peptide analog with a complex molecular structure. Despite its clinical importance, prior to this study, there was no official pharmacopoeial standard for the quantitative analysis of atosiban and its related impurities in pharmaceutical formulations. Accurate quantification of both the main compound and its related substances is critical for ensuring drug safety, efficacy, and regulatory compliance. The presence of impurities can impact therapeutic performance and patient safety; therefore, robust analytical methods are essential for quality control. This study addresses this gap by developing and validating a novel HPLC method tailored for the simultaneous determination of atosiban and five structurally related impurities within atosiban acetate injection. The significance lies in its potential to standardize quality assessment and provide a reliable tool for pharmaceutical manufacturers and regulatory bodies. Experimental Design and Methodo