Analytical methods used for testing of pharmaceutical raw materials and finished products are often transferred across organizations or to contract partners that utilize instruments from different vendors. It is therefore essential for the analytical laboratories to successfully transfer these methods, to ensure product consistency and compliance with regulations. Effective method transfer generates equivalent results for the same analysis, independent of the instrument, laboratory, or the resources. This is important to eliminate the need to revalidate the method, which is time consuming and costly.
Here, we present a transfer of the HPLC method for related substances analysis of metoclopramide HCl from an Agilent 1100 Series LC System to an ACQUITY Arc System. The success of the method transfer to the new instrumentation will be measured by examining the chromatographic separation for comparable results, and verifying that the system suitability results meet the specifications defined in the USP General Chapter <621> Chromatography.