The Analytical Method Development and Validation of Rocuronium Injection Residue Swabs using RP-HPLC

The purpose of the cleaning validation is to determine whether the cleaning procedure used in the parenteral department is capable of limiting drug residues to a predetermined acceptable level. The cleaning validation is intended to reduce cross contamination, which is a major concern in multipurpose pharmaceutical formulation plants. The difficulties in swab recovery studies were addressed in this study. According to the P.I.C.O.S 2007, study, the candidate drug, rocuronium bromide, is used in the parenteral production line. Rocuronium bromide, with a MACO value of 131.25 mg, was discovered to contaminate the most in the group. The recovery of SS, PTFE, and Silicone was estimated to be between 50 and 130%. Various method validation parameters such as accuracy, precision, specificity, linearity and range, intermediate precision, and robustness are used to develop and validate the HPLC method. The recovery studies are performed with a Rocuronium swab with a polyester tip. Swabbing time and pattern are developed, and the method is validated using the previously mentioned method validation parameters.