ANALYTICAL METHOD VERIFICATION BY RP-HPLC FOR CLEANING VALIDATION OF EQUIPMENT USED IN MANUFACTURING IBUPROFEN TABLETS

Background: Effective cleaning validation and reliable analytical methods are critical components of pharmaceutical quality assurance, particularly in multi-product facilities. Residual drug presence on manufacturing equipment poses risks of cross-contamination, making method verification and cleaning validation essential for regulatory compliance. This study aimed to verify a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the assay of Ibuprofen in Ibuprofen Tablets BP 800 mg and to validate the cleaning procedure for equipment used in its manufacture. Methods: Method verification was conducted for key parameters including specificity, precision, ruggedness, and solution stability as per ICH Q2(R1) guidelines. The validated method was then applied to analyze swab and rinse samples collected post-cleaning from three consecutive manufacturing batches. Microbial monitoring and rinse water quality assessment were also performed. Results: The RP-HPLC method demonstrated high specificity with no placebo interference, precision with %RSD < 0.3%, and solution stability up to 24 hours. Cleaning validation data showed that residual ibuprofen levels were below the Maximum Allowable Carryover (MACO) limit of 7 µg/4 sq. inch. Microbial contamination and rinse water parameters remained within acceptable regulatory limits across all equipment surfaces. Conclusion: The verified RP-HPLC method is suitable for routine assay determination of Ibuprofen Tablets BP 800 mg. The cleaning procedure effectively eliminates chemical and microbial residues and can be reliably implemented in ongoing and future manufacturing batches to ensure GMP compliance and product safety.