Cleaning Method Validation for Estimation of Herbal Tablet Residues on Manufacturing Equipment using High Performance Liquid Chromatography

Objectives: This study focuses on developing and validating a cleaning procedure for the equipment used in manufacturing of herbal tablets containing boswellic acid as the target analyte. Due to its high concentration (66.8 mg/tablet) and limited water solubility which is a challenge for cleaning the parts of manufacturing equipments. Methods: A risk - based approach was adopted to identify key sampling points of the manufacturing equipment and samples were collected using rinse sampling and swab sampling methods. Rinse samples were analysed using UV spectrophotometry, while swab samples were examined using high-performance liquid chromatography method. Findings: The validation confirmed the method's reliability in terms of specificity, sensitivity, precision, accuracy, and robustness, compliance with regulatory standards. The findings showed that all equipment surfaces complied with the predefined limits for residual boswellic acid (NMT 0.000349% for swabs and 10 ppm for rinses). Novelty: This study successfully developed a method framework for cleaning validation, ensuring equipment cleanliness, regulatory compliance, and the production of high-quality and contamination-free herbal medicines. Keywords: Boswellic Acid, Accuracy, Precision, Cleaning Validation, Regulatory Standards