Abstract
ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR RESIDUAL OXALIPLATIN TESTING ON INDUSTRIAL MANUFACTURING EQUIPMENTS

Tasneem Fatima*, Anupama Koneru, Murali Balaram Varanasi and Imam Pasha S.

ABSTRACT

This paper describes the analytical method for residual Oxaliplatin testing on manufacturing equipment and is used in cleaning verification of manufacturing equipment to ensure a high degree assurance. Proposed method is proven to be sensitive, simple and accurate for quantification of residual Oxaliplatin. Retention time of Oxaliplatin was found to be 8.903 with isocratic flow rate of 0.8 mL/min at detection wave length of 210nm with 40°C column oven temperature, LOD, LOQ concentrations of Oxaliplatin was found to be 0.06ppm and 0.12ppm respectively.

Keywords: Oxaliplatin; Residual; Cleaning Validation; Swab sampling, Manufacturing Equipment.


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