Development and validation of RP-HPLC method for determination of amoxicillin residues and application to NICOMAC coating machine

The Cleaning Validation protocol plays an important role in the field of pharmaceutical industries its main task is the verification of cleaning procedures to ensure that complete removal of product residues degradation products preservatives excipients cleaning agents and cross contamination of the previous active ingredients A new RP HPLC method is evaluated for determination of Amoxicillin AMO residues in NICOMAC coating machine using Betabasic C mm x mm micro m or equivalent mobile phase of a mixture of M sodium dihydrogen phosphate methanol v v adjusted to pH with orthophosphoric acid at a flow rate of mL min injection volume mu L and UV detection at nm The retention time of AMO is min and the total run time is min A Linear relationship is obtained in the range to ppm with a correlation coefficient of limit of detection mu gmL and limit of quantitation of mu gmL The overall recovery is plusmn the relative standard deviation for precision and intraday precision is less than The validation of the method is performed according to ICH guidelines and USP requirements for new methods which include accuracy precision specificity LOD LOQ robustness ruggedness linearity and range