PharmSky was challenged to develop an Analytical Method for a client to characterise a small, polar molecule with poor UV absorbance for a new formulation.
Traditionally, liquid chromatography (LC) methods to support early-stage product development are used to monitor the drug component and related impurities for lead candidate selection.
Combining a systematic approach with their decades of collective experience, PharmSky scientists designed a simple sample preparation procedure to minimise carry-over errors and ensure method robustness and reliability. Working sample strength, method sensitivity, linearity, specificity (to eliminate interference from formulation excipients) and stability indicating characteristics were considered to get it right the first time.
The result is a user-friendly method that is transferable across to client’s laboratories and to CMOs, is cost-effective and fit for purpose throughout the development lifecycle.
The same approach has been used to overcome hurdles in established LC methods for other clients. A systematic investigation discovered that inconsistency of the standard response of consecutive injections was not related to carry-over or the stability of the standard solution. Modification of the mobile phase and method of quantitation provide clients with a robust method.
