DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF ARIPIPRAZOLE IN SWAB SAMPLES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT SURFACES FOR CLEANING VALIDATION

摘要

Objective: To validate simple analytical method and its application in the determination of residual aripiprazole in production area equipment and to confirm the efficiency of cleaning procedure. Methods: The swab sampling and UV method for residual estimation of aripiprazole in swab samples from equipment surfaces after manufacturing of three consecutive batches of aripiprazole 10 mg uncoated tablets were developed and validated. Results: The swab sampling method was developed and validated in order to obtain the suitable recovery (>90%). The swabs were saturated with acetonitrile. The UV method was developed using UV-Vis spectrophotometer at 255 nm. The calibration curve was linear (r 2 =1.0000) over a concentration range of 1-30 μg/ml. The LOD and LOQ were 0.43 μg/ml and 1.32μg/ml, respectively. No interference from swab solution was observed and samples were stable for 24h. The determined concentration varying from 1.00-5.687μg/swab was well below the calculated limit of contamination i.e., 24.2μg/swab or 24.2 μg/25 cm 2 . Conclusion: The results obtained from cleaning procedure confirmed that the proposed procedure was able to remove aripiprazole from equipment surfaces below the value of 10 ppm criteria. So the proposed validated UV method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of aripiprazole.