Recently, both the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) have published drug quality analysis methods using UPLC® technology.
USP method Tramadol Hydrochloride Extended Release Tablets (Tramadol Hydrochloride Extended Release Tablets) related substances analysis, using the column "L1, 1.7μm, 2.1mm × 10cm" (ACQUITY UPLC® BEH Shield RP18) with UPLC technology platform. The EP method Nevirapine Hemihydrate uses ACQUITY UPLC HSS T3 (1.8μm, 2.1 × 50 mm) chromatographic column with UPLC technology platform.
In its response to the public opinion of tramadol hydrochloride sustained-release tablets, the USP Expert Committee mentioned: “This method proposal reflects USP ’s attempt to introduce new technologies into regulatory standards. The use of UHPLC systems helps save solvent consumption and analysis time, which is different from today ’s The laboratory practices are consistent. "
The content determination method and fingerprint method of a compound Danshen dripping pill in the 2010 edition of the Chinese Pharmacopoeia use UPLC technology (ACQUITY UPLC HSS T3, 1.8μm, 2.1 × 100mm), and the spectrum acquisition time is only 10min. In 2011, the Chinese Pharmacopoeia Commission continued to publish online the detection methods using UPLC technology, including the determination of Hugan Capsule and Hugan Granules (ACQUITY UPLC HSS T3, 1.8μm, 2.1 × 100mm), and injection of Acanthopanax Determination of the content of the liquid (ACQUITY UPLC BEH C18, 1.7 μm, 2.1 × 100 mm), the running time of these analytical methods is 17 minutes and 15 minutes, respectively.
Chinese Pharmacopoeia 2010 edition, page 907: Compound Danshen dripping pills fingerprint spectrum, using Waters Acquity UPLC HSS T3 (column length 100mm, inner diameter 2.1mm, 1.8μm) chromatographic column.
UPLC technology not only improves the resolution and sensitivity to the greatest extent, but also reflects the maximum efficiency of saving time and solvent, which meets the requirements and trends of today's industrial society for improving efficiency, reducing costs, and saving energy and reducing emissions.
Waters® has released the world's first UPLC system (ACQUITY UPLC) since 2004, and the technology has continued to develop and improve. Now it has: UPC2TM, UPLC I-Class UPLC H-Class, UPLC H- Class Bio, nanoACQUITY UPLC®, 2D UPLC, PATROL UPLC and a series of ultra-efficient system platforms that should meet the needs of different technical fields and applications.
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