abstract

This study presents the development and validation of a gas chromatography-mass spectrometry (GC-MS) method for the determination of volatile contaminants in drug products. Ensuring the safety and efficacy of pharmaceutical products is crucial, and the presence of volatile contaminants can significantly impact these factors. The developed GC-MS method aims to provide a reliable analytical procedure for detecting and quantifying such contaminants. The method is validated in accordance with International Council for Harmonisation (ICH) guidelines, encompassing specificity, linearity, accuracy, precision, and robustness. The method's capacity to distinguish volatile contaminants without interference from other elements in the drug products serves as proof of its specificity. Linearity is established through calibration curves with correlation coefficients (R) exceeding 0.999, ensuring consistent and proportional responses across the tested concentration range of 0.1–10 g/mL. Accuracy is evaluated via recovery studies, with recovery rates ranging from 98% to 102%, indicating the method's reliability in quantification. Repeatability and intermediate precision tests with relative standard deviations (RSD) under 2% highlight the reproducibility of the method. Robustness is assessed by making deliberate minor changes to method parameters, which show that the method remains reliable under varying conditions. The approved GC-MS method is then used to measure volatile contaminants in drugs that are already on the market. This shows that it can be used in real life. This method provides a robust tool for routine quality control in pharmaceutical manufacturing, ensuring the safety and quality of drug products by accurately detecting and quantifying potential volatile contaminants.