Beractant

This study aimed to develop and validate an HPLC‐RI method for the simultaneous determination of dipalmitoylphosphatidylcholine (DPPC), palmitic acid, and cholesterol in bovine pulmonary surfactant, a critical treatment for infants suffering from Respiratory Distress Syndrome (RDS). The Iranian surfactant, Beraksurf, was used as the sample. A simple extraction procedure involving methanol dissolution and protein precipitation was employed, followed by HPLC analysis. The method underwent comprehensive validation for various parameters, including system suitability, repeatability (intra‐assay precision), intermediate precision, linearity, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness. The results demonstrated excellent system suitability. Repeatability and intermediate precision were confirmed with low %RSD values, while linearity was established with correlation coefficients (R2) exceeding 0.99 for all analytes. The method exhibited high accuracy, with recoveries ranging from 97% to 100%, and low LOD and LOQ values, indicating its sensitivity. Robustness testing revealed that minor variations in method parameters did not significantly impact results. This validated RP‐HPLC‐RID method provides a reliable and efficient approach for the analysis of key surfactant components, contributing to improved quality control in surfactant preparations and enhancing therapeutic strategies for managing RDS in infants.