Development and Validation of Quantitative Determination and Sampling Methods for Acetaminophen Residues on Pharmaceutical Equipment Surfaces

摘要

The present study concerns the development and validation of rapid and selective high performance liquid chromatographic (HPLC) method for quantitative estimation of acetaminophen residues in samples collected from pharmaceutical manufacturing equipment surfaces and the development of the methodology of establishing the allowable limits for cleaning validation. The developed swab and rinse sampling procedures and HPLC method were validated with respect to accuracy, system suitability test, specificity, linearity, limit of detection (LOD) and quantitation (LOQ). The calibration curve is linear r~2=99999 over a concentration range 0.00002-0.01 mg/ml; LOQ - 0.0002 mg/ml and LOD - 0.00002 mg/ml.