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Published: 2024-08-28

Keywords:Method Development, Cleaning Validation, RP-HPLC

ABSTRACT

The development and validation of a robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for estimating residual content on cleaned manufacturing equipment is crucial for ensuring product safety and compliance with regulatory standards in the pharmaceutical industry. This study outlines the creation of an RP-HPLC analytical protocol designed to detect and quantify trace amounts of residual pharmaceutical compounds post-cleaning. Method development focused on optimizing parameters such as the choice of column, mobile phase composition, flow rate, and detection wavelength to achieve high sensitivity, specificity, and reproducibility. Validation of the method was conducted in accordance with ICH guidelines, evaluating critical performance characteristics including linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), and robustness. The developed method demonstrated excellent linearity within the tested concentration range, with correlation coefficients exceeding 0.999. Precision studies showed relative standard deviations (RSDs) below 2%, indicating high reproducibility. Recovery rates ranged from 98% to 102%, affirming the method's accuracy. The LOD and LOQ were determined to be sufficiently low to detect trace residues, ensuring that even minimal contamination can be quantified. This validated RP-HPLC method offers a reliable and efficient tool for routine monitoring of equipment cleanliness, thereby enhancing quality control processes in pharmaceutical manufacturing.