Analytical Method Development and Validation Of Docusate Sodium to Determine Residual Solvent by Headspace Gas Chromatography
Abstract
Introduction: The development of reliable analytical methods plays a crucial role in pharmaceutical quality control to ensure the safety, efficacy, and regulatory compliance of drug substances and products. Residual solvents are volatile organic impurities that may remain in active pharmaceutical ingredients (APIs) after manufacturing processes such as synthesis, purification, and crystallization. Since these solvents do not provide any therapeutic benefit and may pose toxicological risks when present above permissible limits, their determination is essential in pharmaceutical analysis. The International Council for Harmonisation (ICH) Q3C(R8) guideline classifies residual solvents based on their toxicity and establishes acceptable exposure limits. Material and Methods: The present study was aimed at the development and validation of a rapid, sensitive, selective, and reliable Headspace Gas Chromatography coupled with Flame Ionization Detection (HS-GC-FID) method for the determination of residual solvents in Docusate Sodium API. The developed analytical method was validated in accordance with ICH Q2(R2) guidelines with respect to specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), limit of quantitation (LOQ), and solution stability. Result and Discussions: The validation results demonstrated that the method exhibited excellent specificity and good linearity with correlation coefficients greater than 0.99 for all selected residual solvents. Accuracy studies showed satisfactory recoveries within acceptable limits, while precision studies indicated %RSD values below 2.5%, confirming the reproducibility of the method. Conclusion: The present study successfully developed and validated a reliable HS-GC-FID method for the determination of residual solvents in Docusate Sodium API.
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