The goal of this document is to educate the reader on how to properly transfer HPLC methods found in the USP-NF (and other Pharmacopeias) to UPLC Technology in order to realize the full benefits of higher throughput, lower costs, and faster time-to-market for routine analysis of generic drugs.

While each application focuses on a particular drug product (tablets, capsules, ointments, and oral suspensions), the process for transferring HPLC methods found in the USP-NF to UPLC follows a standard procedure, which be reviewed and explained so that the reader can adapt the approach for any USP monograph in existence today. The reader will understand how to select a modern chemistry equivalent based on the “L” designation in the USP-NF, transfer the HPLC separation to UPLC, and understand the practices necessary to ensure that the transferred method can be used routinely in a production quality control (QC) laboratory.

The main goals of this document are to demonstrate that compendial methods can be transferred to UPLC Technology in three easy steps, and supply the reader with the best practices for using UPLC for method development and routine analysis of generic drug formulations.

USP compendial methods were transferred from HPLC to UPLC for the following drugs:

• Metformin hydrochloride and related substances
• Budesonide nasal spray (Brand name: Rhinocort by AstraZeneca)
• Irbesartan tablets (Brand name: AVAPRO by Bristol-Myers Squibb and Sanofi-Aventis)
• Mometasone furoate ointment (Brand names: Elocon, Elocom, Elomet, Elosalic by Schering-Plough)
• Telmisartan tablets (Brand name: Micardis by Boehringer Ingelheim)
• Amoxicillin oral suspension
• Donepezil tablets (Brand name: Aricept by Eisai and Pfizer)
• Lamotrigine (Brand name: Lamictal by GlaxoSmithKline)
• Levonorgestrel and ethinyl estradiol tablets
• Ziprasidone (Brand name: Geodon, Zeldox by Pfizer)